New Final Som Thesis

“ROLE OF ANTIBIOTIC PROPHYLAXIS IN OPEN MESH
REPAIR OF PRIMARY INGUINAL HERNIA – A

RANDOMISED PROSPECTIVE STUDY”
THESIS SUBMITTED TO NATIONAL BOARD OF EXAMINATIONS, NEW DELHI
In partial fulfillment of the requirement for the award of degree of
D.N.B. (GENERAL SURGERY)
Under the guidance of

GUIDE
Dr. R K BEHERA, MS (GENERAL SURGERY)
JOINT DIRECTOR & HEAD OF THE DEPARTMENT
DEPARTMENT OF GENERAL SURGERY
CO-GUIDE
Dr. BINAYAK RATH, MS (GENERAL SURGERY)
SENIOR CONSULTANT, DEPARTMENT OF GENERAL SURGERY
Submitted by
Dr. SOMNATH KARAD
JANUARY 2016 SESSION
ISPAT GENERAL HOSPITAL, ROURKELA (ODISHA)

ISPAT GENERAL HOSPITAL
CERTIFICATE BY GUIDE
This is to certify that the thesis entitled “ROLE OF ANTIBIOTIC
PROPHYLAXIS IN OPEN MESH REPAIR OF PRIMARY
INGUINAL HERNIA – A RANDOMISED PROSPECTIVE STUDY”
is a bonafide and genuine research work carried out by Dr. SOMNATH
KARAD for DNB examination in General Surgery to be held in
December 2018.
Dr. R. K. Behera
Date:
Joint Director & Head of the Department
Place: Rourkela Department of General Surgery
Ispat General Hospital
Rourkela, Odisha

CERTIFICATE BY CO GUIDE
INGUINAL HERNIA –A RANDOMISED PROSPECTIVE STUDY”
December 2018.
Dr. B Rath
Date: Senior Consultant

Rourkela, Odisha
CERTIFICATE BY THE HOD
December 2018.
Dr. R. K. Behera
Date: Joint Director& Head of the Department
Rourkela, Odisha

ENDORSEMENT BY THE HEAD OF THE INSTITUTION
This is to certify that, Dr. SOMNATH KARAD has prepared the thesis
entitled “ROLE OF ANTIBIOTIC PROPHYLAXIS IN OPEN MESH
REPAIR OF PRIMARY INGUINAL HERNIA –A RANDOMISED
PROSPECTIVE STUDY” in the Dept. of General Surgery, Ispat General
Hospital, Rourkela, Odisha, as set forth in the regulation for Diplomate of
National Board of Examinations, New Delhi.
Dr. S.S.Pati
Date: Director, I/C (M&HS)
Place: Rourkela Ispat General Hospital
Rourkela, Odisha.
COPYRIGHT
NATIONAL BOARD OF EXAMINATIONS, NEW-DELHI
DECLARATION BY CANDIDATE
I hereby declare that, National board of Examinations, New-Delhi, shall

have the rights to preserve, use and disseminate this thesis in print or
electronic format for academic and research purpose.
Dr. Somnath Karad

DNB trainee
Date:
Dept. of General Surgery
Place: Rourkela
Rourkela, Odisha
DECLARATION BY CANDIDATE
I hereby declare that this Thesis “ROLE OF ANTIBIOTIC

has been prepared by me under the guidance of Dr. R K BEHERA (MS,
GENERAL SURGERY)Joint Director & Head of the department, General
Surgery, Ispat General Hospital, Rourkela, Odisha as a part of my
postgraduate course in partial fulfillment of the regulations of National
Board of Examinations, New Delhi, for the award of “Degree of DNB
(General Surgery), Examination to be held in December2018”
I solemnly declare that this Thesis has not formed the basis for the award
of degree or diploma to me previously from any university or board.
Dr. Somnath Karad

Date:
Place: Rourkela DNB trainee
Dept. of General Surgery
Rourkela, Odisha
DISCLAIMER
No benefits in any form have been received or will be received from any
commercial party related directly or indirectly to the subject of this article.
No funds were received in support of this study.
ACKNOWLEDGEMENT
I bow my head to the almighty God for the strength, endurance and perseverance he has
granted. I have always felt his presence in the form of respected teachers while sailing
through high and low challenges of my career, thus moving successfully towards my
destination and serving the purpose dutifully that I am here for.
It’s my great privilege and earnest duty to register my humble and respectful gratitude
towards my experienced and esteemed teacher and guide Dr. R K Behera, Joint Director
and Head, Department of General Surgery, Ispat General Hospital and my co-guide Dr.
Binayak Rath. Words are inadequate to express my sincere and deepest feelings of
gratitude for their kind affection, meticulous supervision and critical appreciation in
execution of my work and for all the trust they had in my ability primarily responsible
for the present accomplishment. I am grateful to have them as my guide and co guide.
I express my deepest sense of gratitude and indebtness to Dr. B N Sarkar, Dr. M K

Panigrahi, and Dr J R Sahoo for their support and valuable guidance throughout my
academic stay with this institute.
I owe my regards to Dr. S.S.Pati, Director I/C (M&HS), Ispat General Hospital,
Rourkela, Odisha for permitting me to carry on this study.
I would like to extend my thanks to all the staff members of the Department of General
Surgery who have whole heartedly co-operated and helped me during my study.
I would like to thank all my seniors, friends ,colleagues and juniors specially Dr.
Praveen kumar , Dr. Sabita , Dr. Swopna sagar, Dr.Kavin, Dr.Akash, Dr. Imran, Dr.
Siddharth, Dr.Narayan and Dr.Deepak for being there for me in the time of need.
Above all, I am thankful to my Mom , Dad and especially my love Dr. Suchita for their
guidance, love and constant support that has brought me so far in life.
A special thanks to all my patients who formed the pillars of my study and without
whom this study would not have been possible.
Dr. Somnath Karad

LIST OF ABBREVIATIONS
LC = Laparoscopic cholecystectomy
OC = Open cholecystectomy
NOTES = Natural Orifice Transluminal Endoscopic Surgery
USG = Ultrasonography
GB = Gall bladder
OCG = Oral Cholecystography
CT = Computerised Tomography
MRI = Magnetic Resonance Imaging
MRCP = Magnetic Resonance Cholangiopancreatography
DM = Diabetes Mellitus
ESWL = Extracorporeal Shock Wave Lithotripsy
MTBE = Methyl Tetra Butyl Ether
US FDA = Food and Drug administration in USA
TLC = Total leucocyte count
PPV = Positive predictive value
NPV = Negative predictive value
AC = Acute cholecystitis
ERCP = Endoscopic retrograde cholangiopancreatography
BMI = Body mass index
COPD = Chronic obstructive pulmonary disease
LFT = Liver function tests
mm = Millimetre
min = Minute
LIST OF CONTENTS
Serial No. Contents Page No.
1. Introduction 1
2. Aims & Objectives 3
3. Review of Literature
4. Material & Methods
5. Observations & Results
6. Discussion
7. Summary
8. Conclusion
9. Recommendations
10. References
11. Annexures
I. Illustrations
II. Patient information sheet
III. Informed consent form
IV. Study Proforma
V. Master chart
LIST OF FIGURES
Fig No. Figure Page No.
1. Anatomy of the extrahepatic biliary tree 5
2. Diagrammatical representation of hepatocystic triangle and Calot’s 6

triangle
3. Ultrasound examination: Gall stone noted at the neck of the gall bladder 9
with associated posterior acoustic shadowing.
4. A brief graphic description of the OT set used in our study 30
5. Age distribution of the study population 34
6. Sex distribution of the study population 35
7. Distribution of the GB wall thickness in study population 36
8. Distribution of GB stone mobility in the study population 37
9. Distribution of GB size in the study population 38
10. Distribution of CBD diameter in the study population 39
11. Prediction of difficulty on USG 40
12. Intraoperative outcome on LC 41
13. Conversions from LC to OC 42
14. Total time of operation during LC 43
15. Time taken to dissect Calot’s triangle 44
16. Time taken to dissect GB from GB fossa 45
17. Cases with difficult extraction 46
18. Diagnostic accuracy of preoperative USG parameters in predicting 52

difficulty during LC
19. Diagnostic accuracy of all preoperative USG parameters in predicting 53

conversion to OC
20. Laparoscopytower 74
21. Digital laparoscopy camera -Front panel 75
22. CO2 insufflator 75
23. Light source 75
24. Electrosurgical unit 76
25. Laparoscopy instruments 76
26. Steps of laparoscopic cholecystectomy 77
27. Critical view of safety 78
28. Dense adhesions at Calot’s triangle 79
29. Ultrasonographic pictures of gall stone disease 80

LIST OF TABLES
Table Table Page

No. No.
1. Age Distribution of the study population 34
2. Sex Distribution of study population 35
3. Distribution of GB wall thickness in the study population 36
4. Distribution GB stone mobility in the study population 37
5. Distribution GB size in the study population 38
6. Distribution of CBD diameter in the study population 39
7. Prediction of difficult cases on USG 40
8. Difficult cases on LC 41
9. Conversion from LC to OC 42
10. Total time of operation in the study population 43
11. Time taken to dissect Calot’s triangle 44
12. Time taken to dissect GB from GB fossa 45
13. Cases with difficult extraction 46
14. Correlation of preoperative USG predictions with difficulties during LC 47
15. Correlation of preoperative USG predictions with conversion to OC 47
16. Correlation between GB wall thickness and difficulties during LC 48
17. Correlation between GB wall thickness and conversion to OC 48
18. Correlation of GB size with difficulties during LC 49
19. Correlation of GB size with conversion to OC 49
20. Correlation of the mobility of the GB stone with difficulty in LC 50
21. Correlation of the mobility of GB stone with conversion to OC 50
22. Correlation of CBD diameter with difficulty in LC 51
23. Correlation of CBD diameter with conversion to OC 51

24. Diagnostic accuracy of preoperative USG parameters in predicting difficulty 52
during LC
25. Diagnostic accuracy of all preoperative USG parameters in predicting 53
conversion to OC
26. Multivariate logistic regression table showing correlation of USG parameters 54
with difficult LC
27. Comparison of various studies with respect to USG prediction of difficult LC 57
28. Comparison of various studies for correlation between GB thickness and 58

difficult LC
29. Comparison of various studies for correlation between contracted GB and 60
difficult LC
30. Comparison of various studies for correlation between impacted gallstones and 61
difficult LC
INTRODUCTION
Hernias are one of the most common anatomical derangements in men and women all over
the world. Egyptians (1500 BC), Phoenicians (900 BC) and Ancients Greeks (400 BC) all
described the diagnosis of hernia and various treatment methods.(1) The word hernia is
derived from Greek word ‘hernias’ meaning a bud or shoot. It refers to protrusion of an organ
through the wall covering it. (2)
Hernias can occur at many sites in our body like inguinal, femoral, umbilical, lumbar, Para
umbilical, epigastric etc.75 % of them occur in the groin, inguinal hernia being the most
common form (3). Surgical management is the treatment of choice for inguinal hernia. Over
the years technique of hernia repair is evolving with Lichtenstein’s tension free mesh repair
being the “gold standard” now a day (4, 5, 6). Inguinal hernia repair is one of the most
common operations performed by general surgeons worldwide and in India (7). More than
one million inguinal hernia repairs are being performed every year in the USA and Europe,
and the figure is likely to be same for India.
Inguinal hernia repair is associated with postoperative complications like seroma, hematoma,
neuralgia, urinary retention and surgical site infection (SSI). SSI is one of the common
complication of hernia surgery, Postoperative wound infection occur in 0%-9% of inguinal
hernia repairs. (8)
The use of antibiotic prophylaxis to avoid surgical infection is routine and very common.
Antibiotic prophylaxis is recommended in ‘clean-contaminated’ procedures and clean’
procedures’ such as Hip or knee arthroplasties, cardiac or vascular graft where foreign
material is used (9). Open non implant herniorrhaphy is classified under ‘clean surgery’
where routine use of antibiotic prophylaxis is not recommended but when mesh is used it has
been associated with a theoretical increase in risk of infection which makes use of
prophylactic antibiotics a necessity (10).
The per-patient cost of prophylaxis estimated by Aufenacker et al. is approximately
13.54 Euro. Since 70% of hernia repair procedures are carried out in patients at a low risk of
perioperative infections, avoidance of using unnecessary prophylaxis could save 10 million
Euro in the US and Europe.(11) In developing country like India where Government
institutions have limited funds, irrational use of antibiotics in a common procedure like hernia
mesh repair will have greater influence on cost effectiveness. Unwarranted administration of
antibiotics may cause an alarming emergence of drug resistance or super infections. Drugs
used for antibiotic prophylaxis also have the risk of toxic and allergic side effects. So
withholding the use of antibiotic prophylaxis in inguinal hernia repair can reduce the possible
development of bacterial resistance or super infections, the risk of toxic and allergic side
effects and overall monetary burden. (12)
Over the past decade many studies have been done to know the beneficial value of
antibiotic prophylaxis in prevention of postoperative wound infection after elective tension
free open mesh hernia repair. Most double-blind randomised controlled trials (RCTs) do not
confirm that use of antibiotic prophylaxis statistically reduces the rate of SSI(13……);
however some are in favour of using antibiotic prophylaxis(14………..). Surveys conducted
at hospitals in London and the South East of England shows that majority of surgeons are in
favour of using antibiotic prophylaxis when performing hernia repair procedures with a mesh
(84%). Their opinion is based on their own beliefs and experience.(15)
The European Hernia Society (EHS) does not recommend routine antibiotic
prophylaxis for elective inguinal hernia repair procedures using a mesh in low-risk patients
but recommends considering prophylaxis where there are patient-related risks (recurrence,
old age, immunosuppression) or procedure- related risks (long duration of surgery, drainage).
This applies to centres where the SSI rate for elective clean surgery is below 5%. (16)
Contradictory results from various reported clinical trials investigating the
effectiveness of antibiotic prophylaxis and lack of proper guidelines in India about its use
have complicated the situation. Therefore, we decided to evaluate the effectiveness of
prophylactic antibiotic in tension free open mesh repair of primary inguinal hernia.
AIM AND OBJECTIVE
AIM
To study the role of antibiotic prophylaxis in tension free open mesh repair of primary
inguinal hernia.
OBJECTIVE
To study postoperative SSI after tension free open mesh repair of primary inguinal hernia.
REVIEW OF LITERATURE
Historical aspect:
Since the down of surgical history, hernias have been subject of interest and their treatment
has evolved through several stages. The history of hernia is the history of hernia surgery.8
The history of hernia begins as early as Greco-roman era, the earliest recorded reference
appearing in the egyptcian papyrus of ebers (crica 1552 BC)9
The ancient hindu surgeons treated hernia by severing the sac and cautery.10
Heliodorus was the surgeon who performed the first hernia operation. He separated the sac
from the cord, twisted of the sac, and ligated the vessels, without touching testicles or
reconstructing the posterior wall of the inguinal canal.11
The middle ages and the Renaissance era saw several further improvements related to the
subject of hernia. Paul of Aegini (AD?607 or 62590) ,Greece Alexandria, Egypt , performed
hernia surgery using double ligation and excision en vas of the cord, sac and testicle. He used
the term enterocele if the sac contain intestine, epiplocele if it contained omentum (from yhe
Greek epiploae- omentum), and hydroenteroepiplocele if it contained intestine, omentum and
fluid 12
Franco was the first to describe, and perform , an operation for strangulated hernia13
Ambrose(1510-90) advocated the use of truss for hernia treatment.14
Lorenz heister (1683-1758) differentiated direct from indirect hernias.15
Through the 18th and 19th century there were many developments both in anatomy of the
inguinal region as well as hernia surgery.
In 1754 Albercht von Haller (1708-77) described congenital hernias.16
Peter Camper 1722-89 in holand campers fascia and the surgical anatomy of the inguinal
hernia.17
Franz k. Hesselbach 1759-1816 in Germany described Hesselbach triangle .18
Astley paston cooper 1768-1841 described the ligament of cooper (pectineal), the cremasteric
fascia and the fascia tranversalis.19
Anders Adolph retzius described the retropubic space or the cave of retzius .20
George lothessei 1868-1935 of Austria was the first to use coopers ligament for repair.21
Lucas-champiolniere 1843-1913 advised incision of the apponeurosis of the external oblique
from the external ring to the arc of the internal ring and removal of the peritoneal cast 22
Elbarado bassini 1844-1924 recommanded approximation , with interrupted sutures of the

layer of the internal oblique , transverse abdominus muscle and transversalis fascia to the
shelvimg border of the inguinal ligament, leaving the cord under the apponeurosi of the
external oblique. This being the original bassini repair.
The 20th century saw the introduction of prosthetic mesh and also other improvements in the
repair of hernias.
henry O. Maecy 1837- 1924 inroduced reconstruction of inguinal ring, antiseptic use of
animal sutures, and high ligation of hernia sac. 24
G.L.Cheatle was the first to introduce the preperitoneal procedure.25
Musgrove and McEvedy sutured the inguinal ring to the iliopectineal ligament. 26
McEvedy sutured the conjoint tendon to the iliopectineal ligament.27
Hull and ganey sutured the inguinal ligament to iliopectineal ligament.28
E.Shouldice 1891-1965 of Toronto repaired the inguinal hernias by overlapping layers, with
continuous suture.29
Chester McVay advised suturing the transverse abdominis arch to coopers ligament.
A sutureless version of Lichenstein technique, traversing the internal ring to place a
prosthetic graft between the peritoneum and the transversalis fascia was creatively described
by Gilbert.30
Robbins and rutkow extended this technique by performing open mesh plug hernioplasty.13
In the last two decades laparoscopy have made significant development in the repair of
hernias.
Ger repaired an indirecr inguinal hernia laparoscopically in 1982.31
Arregui introduced TAPP in 1991.32
Anatomy:
The Latin word hernia means a rupture or tear.33

A hernia is a protrusion of a viscus or part of a viscus through an opening in the wall of the
cavity in which it is contained.34
The inguinal canal is an oblique intermuscular slit, about 4 cm long, lying above the medial
half of the inguinal ligament. It commences at the deep inguinal ring and ends at the
superficial ring.35 It is directed downwards, forwards and medially. In infants, the superficial
and deep inguinal rings are almost superimposed and obliquity of the canal is slight.36
The deep ring is a U shaped condensation of the transversalis fascia and it lies 1.25cm above
the inguinal ligament, midway between the symphysis pubis and the anterior superior iliac
spine.36
The superficial inguinal ring is a triangular aperture in the aponuerosis of the external
oblique and lies about 1.25cm above the pubic tubercle. The ring is bound by a superomedial
and an inferolateral crus joined by crisscross intercrural fibres. Normally the ring will not
admit the tip of the little finger.36
The inguinal ligament is the folded lower border, of the aponeurosis, of the external oblique,
presenting a grooved superior abdominal surface (the floor of the inguinal canal). The
inguinal ligament stretches from the anterior superior iliac spine to the pubic tubercle. It has
variously been called the crural arch, the superficial crural arch and Poupart's ligament.37
Boundaries of the inguinal canal38

The Anterior wall is formed by the following structures:
In its whole extent:
a) Skin
b) Superficial fascia
c) External oblique aponeurosis
In its lateral 1/3 rd: -- Fleshy fibres of the internal oblique muscle.
The Posterior wall is formed by the following structures:

In its whole extent:
a) Fascia transversalis
b) Extra peritoneal tissue
c) Parietal peritoneum
In its medial 2/3rd:
a) Conjoint tendon
b) Reflected part of inguinal ligament (medial end)
In its lateral 1/3rd:
Interfoveolar ligament (when present)
Roof
Roof is formed by arched fibres of the internal oblique and the transverses abdominis
muscles.
Floor
Floor is formed by Grooved upper surface of the inguinal ligament, along with the lacunar
ligament in the medial end.
Structures passing through the canal35:
In males, In females
a) Spermatic cord a) Round ligament
b) Vas deference and its artery b) Lymphatics from uterus
c) Testicular artery c) Obliterated remains of processus
d) Cremastric artery Vaginalis
e) Pampiniform plexus of veins
f) Obliterated remains of processus vaginalis
g) Genital branch of Genitofemoral nerve
h) Autonomic nerves
i) Lymphatics
Hesselbach's Triangle 42
Laterally- inferior epigastric artery
Medially- outer border of rectus
Inferiorly- inguinal ligament
Hesselbach's triangle is divided into medial and lateral halves by the obliterated umbilical
artey (lateral umbilical ligament).
Transversalis fascia43:
This is considered to be the downward continuation of the transversalis muscle and its
aponeurosis. The lower free margin of the muscle arches with the internal oblique muscle
over the internal ring to form the transverses abdominis aponeurotic arch which in turn fuses
with the internal oblique aponeurosis in, 5% to 10% of cases, to form the conjoint tendon.
Iliopubic Tract:
Iliopubic tract is a fibrous condensation of endoabdominal fascia that arises from the
iliopectineal arch and inserts on the anterior superior iliac spine and inner tip of the ileum.
The Iliopubic tract is located at the inferior border of the deep inguinal ring.
Cooper's Ligament:
Cooper's Ligament is located on the posterior aspect of the superior ramus of the pubis and is
formed of periosteum and fascial condensation. It is an important fixation point in
laparoscopic hernia repair as well as in Mcvay‘s repair.
Sites of herniation34:
Hernias of the abdominal wall occur only in areas where aponeurosis and fascia are devoid of
the protecting support of striated muscle. Without a counteracting force, the bare aponeurotic
areas are subjected to the ravages of intra-abdominal pressure and give way if they deteriorate
or contain anatomical irregularities. Predictably, the common sites of herniation are thus the
groin, the umbilicus, the linea alba, the semilunar line of Spieghel, the diaphragm and
surgical incisions. Other similar but rare sites of herniation are the perineum, the superior
lumbar triangle of Grynfeltt, the inferior triangle of Petit and the obturator and sciatic
foramina of the pelvis.
Types of hernia36:
l. lnguinal
2. Femoral
3. Umbilical
4. Obturator
5. Epigastric
6. Paraumbilical
7. Spigelion
8. Diversion of recti
9. Superior lumbar
10. Inferior lumbar
11. Gluteal
12. Sciatic
RISK FACTORS FOR DEVELOPING A PRIMARY
INGUINAL HERNIA (herniasurg)
Numerous risk factors exist for the development of primary inguinal hernias (IH) and
recurrent inguinal hernias (RIH) in adults ranging from acquired to genetic and modifiable to
immutable.
The lifelong cumulative incidence of IH repair in adults is 27–42.5% for men and 3–5.8% for
women.
1. Risk factors associated with IH formation (evidence level—high):
a. Inheritance (first degree relatives diagnosed with IH elevates IH incidence,
especially in females).
b. Gender (IH repair is approximately 8–10 times more common in males).
c. Age (peak prevalence at 5 years, primarily indirect and 70–80 years, primarily
direct).
d. Collagen metabolism (a diminished collagen type I/III ratio).
e. Prostatectomy history (especially open radical).
f. Obesity (inversely correlated with IH incidence).
2. Risk factors associated with IH formation (evidence level—moderate):

a. Primary hernia type (both indirect and direct subtypes are bilaterally
associated).39
b. Increased systemic levels of matrix metalloproteinase-
c. Rare connective tissue disorders (e.g. Ehlers–Danlos syndrome).
3. Risk factors associated with IH formation (evidence level—low):

a. Race (IHs are significantly less common in black adults).
b. Chronic constipation.
c. Tobacco use (inversely correlated with IH incidence).
d. Socio-occupational factors.
e. There is contradictory evidence that social class, occupational factors and
work load affect the risk of IH repair. Heavy lifting may predispose to IH
formation.
4. Risk factors associated with IH formation (evidence level—very low):

a. Pulmonary disease (COPD and chronic cough possibly increasing the risk of
IH formation).48, 49
b. Liver disease, renal disease and alcohol consumption have not been properly
investigated to determine if they are risk factors for IH formation.
PATHOPHYSIOLOGY OF FORMATION OF HERNIA
Indirect
During descent of testes, tunica vaginalis is formed from a tube of peritoneum which
is pulled with testes and wraps around it. The connection of peritoneal cavity to the space in
tunica vaginalis is called as processus vaginalis which should get obliterated due to fibrosis,
possibly under hormonal control. Calcitonin gene-related peptide and hepatocyte growth
factor are seen to have influence on the closure of the processus vaginalis. Failure of
processus vaginalis to obliterate, in its full length or partially, results in descent of bowel
from the peritoneal cavity to inside the tube down towards the scrotum.
Inguinal hernia in neonates and young children is always of this congenital type.
However, in other patients, the muscles around the deep inguinal ring are able to prevent a
hernia from developing until late in life, when due to the factors causing constant positive
abdominal pressure, the deep inguinal ring and muscles get stretched and the hernia becomes
apparent. As the hernia increases in size, the contents are directed down into the scrotum.
An indirect hernia has its origin lateral to the inferior epigastric vessels so called as
‘lateral’ inguinal hernia.
Direct
Direct or medial hernia is an acquired form which results due to stretching and
weakening of the abdominal wall just medial to the inferior epigastric (IE) vessels.
Hasselbach’s triangle is a weak area in the floor of inguinal canal as the abdominal
wall here consists of only transversalis fascia covered by the external oblique aponeurosis.
Direct hernia occurs through this area.
Sliding
An acquired hernia formed due to weakening of the abdominal wall at the deep
inguinal ring lateral to the IE vessels leading to descent of retroperitoneal fatty tissue
downwards along the inguinal canal is called as sliding hernia. Sac is created due to pulling
of peritoneum along with retroperitoneal tissue.
Sigmoid colon (on the left side) and caecum (on the right side) may be pulled into a
sliding hernia needing extra caution from surgeons during repair.
Types of hernia by complexity
1.Occult swelling not detectable clinically; may cause severe pain

2.Reducible swelling which appears and disappears
3.Irreducible swelling which cannot be replaced in the abdomen, high risk of complications
4.Strangulated painful swelling with vascular compromise, requires urgent surgery
5.Infarcted when contents of the hernia have become gangrenous, high mortality
CLASSIFICATION OF INGUINAL HERNIA

The inguinal hernia, often referred to as a ‘rupture’ by patients,
is the most common hernia in men and women but much more common in men.
There are two basic types which are fundamentally different in anatomy, causation and
complications.
However, they are anatomically very close to one another, surgical repair techniques are very
similar and ultimate reinforcement of the weakened anatomy is identical so they are often
referred to together as inguinal hernia
1. The congenital inguinal hernia is known as indirect, oblique or lateral.
2. The acquired hernia is called direct or medial.
3. There is a third ‘sliding’ hernia which is acquired but is lateral in position.
Classification systems
Many surgeons over the past hundred years have attempted to classify inguinal (and femoral)
hernias, including Casten, Halverson and McVay, Zollinger, Ponka, Gilbert and Nyhus.
The European Hernia Society has recently suggested a simplified system of:
 Primary or recurrent (P or R);
 Lateral, medial or femoral (L, M or F);
 Defect size in finger breadths assumed to be 1.5 cm.
A primary, indirect, inguinal hernia with a 3-cm defect size would be PL2.
EHS Groin
Hernia Primary Recurrent
Classification
0 1 2 3 X
L(Lateral)
M(Medial)
F(Femoral)
NYHUS CLASSIFICATION
Type Description
Indirect hernia; internal abdominal ring normal; typically in infants, children
I
and small adults
Indirect hernia ; internal ring enlarged without impingement on the floor of the
II
inguinal canal ; does not extend to the scrotum
A Direct hernia ; size is not taken into account
 Indirect hernia that has enlarged enough to encroach upon the posterior
inguinal wall ;
III B  Indirect sliding or scrotal hernias are usually placed in this category because
they are commonly associated with extension into direct space;
 Pantaloon hernias
C Femoral hernia
Recurrent hernias;
IV modifiers A-D are sometimes added, which correspond to indirect, direct,
femoral ,and mixed respectively
Gilbert (1989) based the classification on the established defects observed intraoperatively
and which include and are based on:
1. Presence or absence of peritoneal sac
2. Size of deep inguinal ring
3. Integrity of the posterior wall
Type Description
Peritoneal sac passing through, deep inguinal ring less than one fingerbreadth and
1
an intact posterior wall – indirect hernia
Peritoneal sac passing through, deep inguinal ring one fingerbreadth and an intact
2
posterior wall – indirect hernia
Peritoneal sac passing through, deep inguinal ring two fingerbreadth or wider and
3
part of posterior wall has broken– indirect hernia
No Peritoneal sac passing through, deep inguinal ring is intact and full breakdown
4
of posterior wall – direct hernia
5 No Peritoneal sac passing through, deep inguinal ring is intact
Rutkow and Robbins (1933) added a Type 6 for double inguinal hernias, the combined direct
and indirect hernia and Type 7 the femoral hernia to this classification system.
DIAGNOSIS OF AN INGUINAL HERNIA HERNIA Surg

Clinical examination (CE) of the groin is the gold standard for hernia diagnosis with a
sensitivity of 0.745 and a specificity of 0.963 reported in a prospective cohort study.86
Only obscure groin pain or groin swelling of unclear origin need further diagnostic
investigation.88, 89. A 2013 meta-analysis revealed that groin US had a specificity of 0.86 and
a sensitivity of 0.77.105 MRI demonstrated a specificity of 0.963 and a sensitivity of 0.945.86
Two studies support the use of CE in combination with US to confirm the diagnosis
of inguinal hernias. CE plus US was found to be superior to CE alone in both studies.89, 96
When groin US is negative or non-diagnostic, dynamic MRI, dynamic CT and even
herniography may be considered in an attempt to establish a diagnosis.117
MANAGEMENT OF INGUINAL HERNIA hernia surg
Approximately one third of inguinal hernia patients are asymptomatic.133 Watchful

waiting strategy can be used for asymptomatic patients but these patients should be
counselled that though watchful waiting is safe, symptoms will likely progress and operation
may be needed. Patient should be informed about natural history of their condition and the
risk of emergency hernia surgery
In case of symptomatic inguinal hernia patients surgery is the best modality of treatment.
Surgical procedures on the inguinal canal account for a fourth of all operative interventions in
general surgery [52]. Inguinal hernia repair can be done by various methods as listed below.
Operations for inguinal hernia

1) Herniotomy
2) Open suture repair
i) Bassini
ii) Shouldice
iii) Desarda
3) Open flat mesh repair
i) Lichtenstein
4) Open complex mesh repair
i) Plugs
ii) Hernia systems
5) Open preperitoneal repair
iii) Stoppa
6) Laparoscopic repair
iv) TEP
v) TAPP
The decision of which operation to be done dependent upon many factors like:
1. Hernia characteristics (size, type, primary/recurrent, reducibility, unilateral/bilateral)
2. Anaesthesia type,
3. Surgeon’s preference, training, capabilities and logistics,
4. Patient’s wish.
According to 2009 European guidelines Shouldice inguinal hernia repair is the best
non mesh technique, in case of mesh repair techniques laparo-endoscopic and open repair
show comparable results in long term follow up of a minimum of 48 months.
Numerous randomised trials and meta-analyses show the procedures using a mesh have
become the gold standard in the surgical repair of inguinal hernia [2, 53, 54]. A mesh based
technique is strongly recommended for inguinal hernia repair because using a mesh have
reduced the rate of recurrence from 15% to less than 1% [55, 56].Flat mesh technique e.g.
Lichtenstein’s repair is favoured over other types like proline hernia system, plug and patch,
self-gripping mesh.
Open flat mesh repair

Synthetic mesh has been used since the 1950s to reinforce hernia repair, and in the 1980s
with Lichtenstein’s tension free mesh repair being the “gold standard” now a day (4, 5, 6)
Lichtenstein described a tension free, simple, flat, polypropylene mesh repair for
inguinal hernia. The initial part of the operation is identical to Bassini. Once the hernia sac
has been removed and any medial defect closed, a piece of mesh, measuring 8 × 15 cm, is
placed over the posterior wall, behind the spermatic cord, and is split to wrap around the
spermatic cord at the deep inguinal ring. Loose sutures hold the mesh to the inguinal ligament
and conjoint tendon. Two major advantages claimed are, lowered hernia recurrence rates and
accelerated postoperative recovery.
Recommended characteristics of mesh used are large mesh pore size (1-1.5mm)
monofilament synthetic flat mesh with burst strength of 16 N/m2 and consisting of minimum
tensile strength of 16 N/m2 in all directions.
S.No Characteristics of ideal mesh

1. Resistance
2. Durability
3. Tissue tolerance
4. Flexibility and memory
5. Non-migration
6. Stability
7. Pervious pores
8. Sterilizability
9. Non-carcinogenic
10. Should block infectious diseases transmission
11. Resist shrinkage
12. Should have the ability to degrade itself over time and be easy to manufacture
13. Minimal adhesion formation
14. Should bear excellent tissue in growth with minimal shrinkage
15. Should allow the formation of seroma but not fistula
16. Promote minimal pain
17. Should not change compliance of abdominal wall
18. Should have elasticity in more than one dimension
COMPLICATIONS OF INGUINAL HERNIA SURGERY

Intraoperative complications
 Injury to vas deference
 Injury to urinary bladder
 Injury to bowel
 Injury to testicular artery
Immediate complications
 Bleeding –
It may be due to accidental damage to the inferior epigastric or iliac vessels.
 Urinary retention.
 Femoral nerve blockade –
Occasional overenthusiastic infusion of local anaesthetic may lead to femoral
nerve blockade, the patient being unable to move a leg. This usually resolves over
12 hours but is alarming.
Early complications
 Seroma formation –
Seroma is due to an excessive inflammatory response to sutures or meshes and
cannot be prevented. In most cases the fluid resolves spontaneously but may
require aspiration. After laparoscopic surgery, a seroma may be misdiagnosed as
an early recurrence.
 Wound infection –
It is not uncommon. Many surgeons use routine prophylactic antibiotics but
recent studies suggest little benefit even when mesh is used.
In the longer term,
 Hernia recurrence
No operation can guarantee to be recurrence free. Evidence shows that mesh
repairs have lower recurrence rates than suture repairs but there is no difference
between the various mesh repairs and no difference between open and laparoscopic
surgery.
 Chronic pain,
It is defined as pain present three months after surgery, is common after all
forms of surgery. Different types of pain have been described but the most severe is
neuralgic pain due to nerve irritation. This may be the result of nerve injury at the
time of operation or chronic irritation of nerves by suture material or mesh. Careful
identification and protection of all three nerves passing along the inguinal canal
reduces the incidence of neuralgic pain.
 Testicular infarction
Rarely, damage to the testicular artery can lead to testicular infarction, perhaps
the most serious complication of inguinal hernia surgery. There is no good evidence
that hernia surgery has an effect on male fertility despite extensive study in this area.
Summary box 60.10
SURGICAL SITE INFECTION

As per CDC criteria SSI can be defined as,
SUPERFICIAL INCISIONAL SSI

Must meet the following criteria:
1. Date of event for infection occurs within 30 days after any NHSN operative procedure
(where day 1 = the procedure date).
AND
2. Infection involves only skin and subcutaneous tissue of the incision.
AND
3. Patient has at least one of the following:
a) Purulent drainage from the superficial incision.
b) Organisms identified from an aseptically-obtained specimen from the superficial
incision or subcutaneous tissue by a culture or non-culture based microbiologic
testing method which is performed for purposes of clinical diagnosis or treatment
(for example, not active surveillance culture/testing (asc/ast).
c) Superficial incision that is deliberately opened by a surgeon, attending
physician** or other designee and culture or non-culture based testing is not
performed.
And
Patient has at least one of the following signs or symptoms: pain or tenderness;
localized swelling; erythema; or heat.
d) Diagnosis of a superficial incisional SSI by the surgeon or attending physician**
or other designee.
** The term attending physician for the purposes of application of the NHSN SSI criteria
may be interpreted to mean the surgeon(s), infectious disease, other physician on the case,
emergency physician or physician’s designee (nurse practitioner or physician’s assistant).
ORGAN/SPACE SSI

1. Date of event for infection occurs within 30 or 90 days after the NHSN operative
procedure (where day 1 = the procedure date).
AND
2. Infection involves any part of the body deeper than the fascial/muscle layers, that is
opened or manipulated during the operative procedure
AND
a) Purulent drainage from a drain that is placed into the organ/space (for example,
closed suction drainage system, open drain, T-tube drain, CT guided drainage)
b) Organisms are identified from fluid or tissue in the organ/space by a culture or
non-culture based microbiologic testing method which is performed for purposes
of clinical diagnosis or treatment (for example, not Active Surveillance
Culture/Testing (ASC/AST).
c) An abscess or other evidence of infection involving the organ/space that is
detected on gross anatomical or histopathologic exam, or imaging test evidence
suggestive of infection.
AND
meets at least one criterion for a specific organ/space infection site listed in Table
3. These criteria are found in the Surveillance Definitions for Specific Types of
Infections chapt
DEEP INCISIONAL SSI

1) The date of event for infection occurs within 30 or 90 days after the NHSN operative
procedure (where day 1 = the procedure date)
AND
2) Infection involves deep soft tissues of the incision (for example, fascial and muscle
layers)
AND
3) patient has at least one of the following:
a) Purulent drainage from the deep incision.
b) A deep incision that spontaneously dehisces, or is deliberately opened or aspirated
by surgeon, attending physician** or other designee
AND
organism is identified by a culture or non-culture based microbiologic testing
method which is performed for purposes of clinical diagnosis or treatment (for
example, not Active Surveillance Culture/Testing (ASC/AST) or culture or non-
culture based microbiologic testing method is not performed
AND
Patient has at least one of the following signs or symptoms:
fever (>38°C); localized pain or tenderness.
Culture or non-culture based test that has negative finding does not meet this
criterion.
c) An abscess or other evidence of infection involving the deep incision that is
detected on gross anatomical or histopathologic exam, or imaging test.
The incidence of SSIs has been estimated to be about 3% in the United States. The incidence
varies greatly from less than 5% for clean surgery to more than 20% for emergency colon
surgery, which is often performed in a dirty field. Moreover, the overall estimate is almost
certainly an underestimate, considering that SSI after ambulatory surgery, which now
represents more than 70% of all operations in the United States, is seldom reported.
The microbiology of SSI depends on the nature of the procedure, location of the incision, and
whether a body cavity or hollow viscus is entered during surgery. Most SSIs are caused by
skin flora inoculated into the incision during surgery; the most common being gram-positive
cocci—Staphylococcus epidermidis, S. aureus, and Enterococcus spp. The most common
causative factors are Staphylococcus aureus and Staphylococcus epidermidis [40, 58, 62].
Risk factors for surgical site infection

It is important to identify the risk factors for SSI to know the group of patient which may be
benefited by the use of prophylactic antibiotics to prevent development of SSI.
Many risk indexes are used to identify risk factors for SSI, the SENIC and NNIS risk indexes
are the commonly used ones [42].
According to the SENIC (Study of the Efficacy of Nosocomial Infection Control) index,
the most important risk factors are :
1. An abdominal operation;
2. An operation lasting more than 2 h;
3. A surgical site with a wound classification of either contaminated or dirty/infected;
4. An operation performed on a patient having more than 3 discharge diagnoses.
Absence of risk factors predicts the SSI rate at 1%, while the presence of 1, 2 and 3factors is
associated with a rate of 3.6%, 8.9% and 17.2%, respectively [30, 43].
According to The NNIS (National Nosocomial Infection Surveillance) system index
following are the risk factors for SSI:
1. A surgical site with a wound classification of either contaminated or dirty/infected.
2. An operation lasting more than 2 h or more than 75% of the time allocated for the
operation.
3. The patient’s ASA score of more than 3.
Absence of the above risk factors is associated with an SSI rate of 1.5%, while the presence
of 1, 2 and 3 factors is associated with a rate of 2.9%, 6.8% and 13.0%, respectively[25, 30,
44, 45]. The NNIS system has certain limitations, as it utilises the (often subjective)
American Society of Anaesthesiologists (ASA) scale [46].
An NNIS risk index of 2, in cases of hernia repair procedures, weighs in favour of using
prophylaxis, although no evidence to support this could be demonstrated in research studies
[47].
In 1964, the US National Research Council (NRC) proposed a classification of surgical
wounds that would predict the risk of SSI. The current classification, modified by the Centre
for Disease Control and Prevention (CDC), distinguishes four classes of wounds: clean,
clean-contaminated, contaminated, and dirty (see Table I) [25, 26].
This classification aims to assess the risk of bacterial infection and potential complications in
the form of SSI in perioperative management [26].
Wounds are divided into four classes as per CDC Criteria.

Sr Class Description Risk of
no SSI
1 Clean An uninfected operative wound in which no
inflammation is encountered and the respiratory,
alimentary, genital, or uninfected urinary tracts are not
entered.
In addition, clean wounds are primarily closed and, if 1-5%
necessary, drained with closed drainage.
Operative incisional wounds that follow nonpenetrating
(blunt) trauma should be included in this category if
they meet the criteria
2 Clean- Operative wounds in which the respiratory, alimentary,
genital, or urinary tracts are entered under controlled
Contaminated
conditions and without unusual contamination.
Specifically, operations involving the biliary tract, 2-9%
appendix, vagina, and oropharynx are included in this
category, provided no evidence of infection or major
break in technique is encountered.
3 Contaminated Open, fresh, accidental wounds.
In addition, operations with major break in sterile
technique (for example, open cardiac massage) or gross
spillage from the gastrointestinal tract.
3-13%
Incisions in which acute, nonpurulent inflammation is
encountered, including necrotic tissue without evidence
of purulent drainage (for example, dry gangrene), are
included in this category.
4 Dirty Includes old traumatic wounds with retained devitalized
tissue and those that involve existing clinical infection
or Infected
or perforated viscera. This definition suggests that the 3-13%
organisms causing postoperative infection were present
in the operative field before the operation.
Management of SSI
Diagnosis
Diagnosis of SSI is mainly based on clinical examination i.e. presenting signs and symptoms
of SSI and is done according to CDC criteria.
Treatment
The first steps in the treatment of SSIs are to open and to examine the suspicious portion of
the incision and to decide about further surgical treatment.104
Treatment of superficial SSI

If the infection is confined to the skin and superficial underlying subcutaneous tissue,
opening the incision and providing local wound care may be all the treatment that is
necessary.
Antibiotic therapy of superficial incisional SSI is indicated only for erythema extending
beyond the wound margin or for systemic signs of infection.
Treatment of deep SSI

Deeper SSIs may require formal surgical exploration and debridement to obtain local control
of the infection.
Treatment of organ space SSI

These deep infections may remain occult or be manifested with few symptoms, mimicking
incisional SSIs and leading to inadequate initial treatment; they become apparent only when a
major complication ensues. The diagnosis of organ or space SSIs usually requires some form
of imaging to confirm the site and extent of infection. Adequate source control requires a
drainage procedure, whether open or percutaneous.
CDC RECOMMANDATIONS FOR SSI PREVENTION
Preoperative Factors
 Preparation of the patient:

1. Identify and treat all remote infections before taking patients for surgery
2. Remove hair only if it interferes with surgery, If it is to be removed, remove
immediately preoperatively using clippers.
3. Ensure good blood glucose control in diabetic patients.
4. Encourage cessation of tobacco use (at least for 30 days before surgery, if possible).
5. Do not withhold blood products, as transfusion does not affect rates of SSI.
6. Require the patient to shower or bathe with an antiseptic solution the night before
surgery.
7. Remove gross contamination from the surgical site before performing antiseptic skin
preparation.
8. Skin preparation with an appropriate antiseptic solution in concentric circles moving
outward toward the periphery.
9. Short preoperative hospital stay.
 Hand/forearm antisepsis for surgical team:

1. Keep nails short and do not wear artificial nails.
2. Perform a preoperative scrub for at least 2–5 minutes up to the elbows.
3. After performing the surgical scrub, keep the hands up and away from the body
(elbows flexed) so that the water runs from the tips of fingers toward the elbows. Dry
hands with a sterile towel and don a sterile gown and gloves.
4. Clean underneath each fingernail.
5. Do not wear hand or arm jewellery.
 Management of infected or colonized surgical personnel:

1. Educate and encourage surgical personnel who have signs and symptoms of a
transmissible infectious illness to report promptly to their supervisor and occupational
health personnel.
2. Develop well-defined policies concerning patient care responsibilities when personnel
have potentially transmissible infectious conditions.
These policies should govern:
(1) responsibility of personnel in using health services and reporting illness,
(2) work restrictions, and
(3) Clearance to resume work after an illness that required work restriction.
The policies should also identify staff members that have the authority to remove
personnel from duty.
3. Obtain appropriate cultures and exclude from duty surgical personnel who have
draining skin lesions until infection has been ruled out, or until these personnel have
received adequate therapy and infection has been resolved.
4. Do not routinely exclude surgical personnel who are colonized with organisms such
as Staphylococcus aureus or group A streptococci, unless they have been linked
epidemiologically to dissemination of the organism.
 Antibiotic prophylaxis:
1. Administer a prophylactic antimicrobial agent only when indicated, and select it based
on its efficacy against the most common pathogens causing SSIs for a specific
operation, and in accordance with published recommendations.
2. Administer by the IV route the initial dose of prophylactic antimicrobial agent, timed
such that bactericidal concentration of the drug is established in serum and tissue
when the incision is made. Maintain therapeutic levels of the agent in serum and
tissues throughout the operation, and for a few hours after the incision has been
closed.
3. Before elective colorectal operations, in addition to the above measures, mechanically
prepare the bowel by using enemas and cathartic agents. Give non absorbable oral
antimicrobial agents in divided doses on the day before the operation.
4. For high-risk cesarean sections, administer the prophylactic antimicrobial agent
immediately after the umbilical cord is clamped.
5. Do not routinely use vancomycin for prophylaxis.
Intraoperative
 Ventilation:
1. Maintain positive pressure ventilation in the operating room with respect to the
corridors and adjacent area.
2. Maintain a minimum of 15 air changes per hour, of which at least 3 should be fresh
air.
3. Filter all air, recirculated and fresh, through the appropriate filters per the American
Institute of Architects’ recommendations.
4. Introduce all air at the ceiling, and exhaust air near the floor.
5. Do not use ultraviolet radiation in the operating room.
6. Keep operating suite doors closed except as need for passage of equipment, personnel,
or patients.
7. Consider performing orthopedic implant operations in an operating suite supplied
with ultraclean air.
8. Limit the number of personnel entering the operating room.
 Cleaning and disinfection of environmental surfaces:

1. When visible soiling or contamination of surfaces or equipment with blood or other
body fluids occurs during an operation, use an Environmental Protection Agency
(EPA)-approved hospital disinfectant to clean the affected areas before the next
operation.
2. Do not perform special cleaning (in addition to cleaning with routine EPA-approved
hospital disinfectant) or closing of operating rooms after contaminated or dirty
operations.
3. Do not use tacky mats at the entrance to the operating room suite or individual
operating rooms for infection control.
4. Wet vacuum the operating floor with an EPA-approved disinfectant after the last
operation of the day or night.
 Microbiological sampling:
1. Do not perform routine environmental sampling of the operating room.
 Sterilization of surgical instruments:

1. Sterilize all surgical instruments according to published guidelines.
2. Perform flash sterilization only for patient care items that will be used immediately.
Do not flash sterilize for reasons of convenience or to save time.
 Surgical attire and drapes:

1. Wear a surgical mask that fully covers the mouth and nose when entering the
operating room if an operation is about to begin or is underway, or if sterilized
instruments are exposed. Wear the mask throughout the operation.
2. Wear a cap or hood to fully cover hair on the head and face.
3. Do not wear shoe covers for prevention of SSIs.
4. Wear sterile gloves if scrubbed as a surgical team member. Put on gloves after
donning the sterile gown.
5. Use surgical gowns and drapes that are effective barriers when wet.
6. Change scrub suits that are visibly soiled, contaminated, and/or penetrated by blood or
other potentially infectious material.
 Asepsis and surgical technique:

1. Adhere to principles of asepsis when placing intravascular devices, spinal or epidural
anaesthesia catheters, or when dispensing or administering IV drugs.
2. Assemble sterile equipment and solutions immediately prior to use.
3. Handle tissue gently, maintain effective haemostasis, minimize devitalized tissue and
foreign bodies, and eradicate dead space at the surgical site.
4. Use delayed primary skin closure or leave an incision open if the surgeon considers
the surgical site to be heavily contaminated.
5. If drain is necessary, use close suction drain and place it through a separate incision
distant from the operating incision. Remove the drain as soon as possible.
Postoperative Incision Care
1. Protect an incision that has been closed primarily with a sterile dressing for 24–48
hours postoperatively.
2. Wash hands before and after dressing changes and before and after any contact with
surgical site.
3. When an incision dressing must be changed, use a sterile technique.
4. Educate the patient and family regarding proper incision care, symptoms of SSI, and
the need to report such symptoms.
SSI AFTER INGUINAL HERNIA REPAIR

Elective inguinal hernia repair procedures are a good example of clean surgical procedures
But implantation of a mesh during a hernia repair procedure is, theoretically associated with a
higher risk of infection [15]
The SSI rate in clean procedures should not exceed 2% [32].But in case of the inguinal hernia
repair procedures it is difficult to establish the actual rate of SSI. Depending on the source,
the rate varies from 0% to 14% which may be due to number of factors like: method of post-
hospitalisation follow- up (SSI diagnosed by the surgeon vs. an independent observer), the
definition of SSI (no definition vs. the CDC definition), duration of post-discharge follow-up
(1 week vs. 1 year), study design based on which the rate of SSI is calculated (retrospective
non-randomised vs. prospective randomised), etc.[51]
The SSI rates may be considerably underestimated as around 50% of SSI are diagnosed after
the patient’s discharge [10–12].
As with other wounds, SSI complicating surgical repair of an inguinal hernia may be
classified into superficial (SSSI) and deep (DSSI) based on the classification developed in
1992 by the CDC [57–59].
The EHS guidelines assume that prophylaxis in clean operative procedures is unnecessary,
except for the patients with multiple risk factors for SSI.[4, 22]. Therefore Classifying
patients into groups at low or high SSI risk for SSI in clean procedures like hernia would
allow us to identify those who should be provided with prophylaxis.
The list of risk factors for SSI after inguinal hernia repair as given in EHS guidelines:
 Patient-related risk factors for infection
1. Recurrence of hernia,
2. Old age (> 70 years),
3. Immunosuppression.
4. Co-morbidities (diabetes mellitus, rheumatoid arthritis, obesity) are also included
among the risk factors [22].
5. Hypoalbuminemia has also been shown to be an independent risk factor for SSI
[1]
 Procedure-related factors
1. A long duration of the operation
2. Drainage (controversial). 40,1,16
Since some of these factors (e.g. drain) are controversial, and their impact on SSI rates is
questioned by some, establishing universal risk factors in the case of hernia repair procedure
is not an easy task. It therefore seems necessary to conduct further studies to establish the
actual risk factors for SSI [5].
Surgical site infection: costs and consequences

Superficial infections associated with inguinal hernia repair procedures are not so dangerous
as they usually require simple drainage with or without systemic antibiotic treatment [61]. So
unnecessary antibiotic prophylaxis can be avoided, which in turn not only will reduce the
costs but also will minimise the risk of allergic reactions and of the emergence of bacterial
resistance [22, 25] leading to significant impact both in medical and economic terms.
The per-patient cost of prophylaxis estimated by Aufenacker et al. is relatively low (13.54
Euro). Avoidance of using unnecessary prophylaxis could, however, save 10 million Euro in
the US and Europe, because 70% of hernia repair procedures are carried out in patients at a
low risk of perioperative infections [1, 68].
On the other hand, DSSI is a serious therapeutic problem and a difficult condition to manage.
They usually require prolonged hospitalisation (usually several hospitalisations) and in some
cases repeat surgery. As concluded by Mann et al. [59] and Taylor and O’Dwyer [61] in
their review literature about the fate of infected inguinal hernia grafts, this condition
frequently necessitates complete removal of grafts [24].
According to Kirkland et al., patients who develop SSI are 60% more likely to require
hospitalisation at an ICU, five times more likely to be readmitted to hospital and twice as
likely to die during the perioperative period compared to patients without SSI [63 ]. But these
are overall data concerning all surgical procedures (not only those for hernia).
In case of inguinal hernia repair according to Davey and Nathwani, the additional cost of
treating a patient with SSI, is 600 US dollars. But the open hernia repair procedure is too
common to ignore such an economical Burdon. And this goes to show that the frequency at
which a given procedure is performed is equally important as its “quality” [69].
As there are no previous studies comparing cost of antibiotic prophylaxis and cost of SSI in
case of open mesh repair of inguinal hernia, it is necessary to make further research regarding
it.
ANTIBIOTIC PROPHYLAXIS
Antibiotic prophylaxis is an administration of a drug aimed at reducing the
intraoperative level of microorganisms to a quantity which can be successfully dealt with by
the patient’s immune system intended to work before bacteria adhere to host tissues or host
proteins in the surgical field or supposed to reduce the quantity of colonising bacteria at that
site [24, 25].
Four principles guide the administration of an antimicrobial agent for prophylaxis112:

1. Safety
2. An appropriate narrow spectrum of coverage of relevant pathogens
3. Little or no reliance on the agent for therapy of infection
(because of the possible induction of resistance with heavy use)
4. Administration within 1 hr before surgery and for a defined brief period thereafter
( no longer than 24 hours, 48 hours for cardiac surgery, and ideally, a single dose)
Antibiotic prophylaxis of surgery does not prevent postoperative nosocomial infections,

which actually occur at an increased rate after prolonged prophylaxis,190 selecting for more
resistant pathogens when infection does develop.42
If it is not administered properly, antibiotic prophylaxis is ineffective and may be harmful.
Antibiotic prophylaxis always poses a risk of causing an allergic reaction or generating
bacterial resistance [33]. Their unnecessary use is also significant from the economic point of
view, as about 30–50% of antibiotics in hospitals are administered for prophylactic purposes
[24, 34].
Guidelines on antibiotic prophylaxis include the indications, the type of antibiotic as well as
the timing and method of its administration [25, 35, 36].
Indications
Situations where potential SSI could lead to dramatic consequences are the ones where
prophylactic antibiotics are recommended [25].
As per CDC classification of wounds, following guidelines are set for the use of perioperative
prophylaxis.
1. Clean wounds in surgery almost always concern elective procedures, which are
carried out under sterile conditions. Prophylaxis is required only in cases involving
the introduction of prosthetic devices or implants and in situations where infection
could pose a high risk to the patient (such as operative procedures in the fields of
cardiothoracic surgery, neurosurgery, orthopaedic surgery and vascular surgery)..
2. The benefits of antibiotic prophylaxis in clean contaminated and contaminated
wounds are indisputable.
3. In cases of dirty wounds, antibiotics are used as a treatment rather than prophylaxis
[27–31].
.
Antibiotic prophylaxis of clean surgery is controversial. When bone is incised (e.g.,
craniotomy, sternotomy) or a prosthesis is inserted, antibiotic prophylaxis is generally
indicated but Some controversy persists with clean surgery of soft tissues (e.g., breast,
hernia). Meta-analysis of randomized controlled trials has shown some benefit of
antibiotic prophylaxis of breast cancer surgery without immediate reconstruction 195,196
but no decrease of SSI rate for groin hernia surgery,197,198 even when non-absorbable
mesh is implanted.
What to give
Most SSIs are caused by gram-positive cocci, so prophylaxis should be directed primarily
against staphylococci for clean cases and for high-risk, clean-contaminated, elective biliary,
and gastric surgery cases. A first-generation cephalosporin is preferred in almost all
circumstances (Table 11-7), with clindamycin used for penicillin-allergic patients.112
If gram-negative or anaerobic coverage is required, a second-generation cephalosporin or the
combination of a first-generation agent plus metronidazole is the first-choice regimen of most
experts.
Optimal time to give

The optimal time to give parenteral antibiotic prophylaxis is within 1 hour before
incision.200
Antibiotics given sooner are ineffective, as are agents given after the incision is closed.
Till when to give

Even though the SCIP specifies a 24-hour limit for prophylaxis, single-dose prophylaxis
(with intraoperative redosing, if indicated) is equivalent to multiple doses for the prevention
of SSI.203
Excessively prolonged antibiotic prophylaxis is potentially harmful as it increases the risk of
nosocomial infections unrelated to the surgical site and of the emergence of MDR pathogens.
But unfortunately, evidence has shown that only 40% of patients who receive antibiotic
prophylaxis do so for less than 24 hours. 111
ANTIBIOTIC PROPHYLAXIS IN HERNIA REPAIR

PROCEDURES
Elective hernia repair procedures are considered to be clean procedures which do not,
as such, require antibiotic prophylaxis [6, 49, 50]. As per EHS guidelines, Antibiotic
prophylaxis is not recommended for procedures carried out without a mesh, and this seems to
be indisputable. [22].But implantation of a mesh during a hernia repair procedure is,
theoretically associated with a higher risk of infection [15] leading to differences in the
opinion among surgeons about use of antibiotic prophylaxis.
According to the surveys conducted at hospitals in London and the South East of England,
more than half of surgeons use antibiotic prophylaxis during hernia repair procedures,
including in low risk patients (i.e. those without risk factors for SSI). They justify their
approach by the presence of an implant, despite the lack of sufficient clinical evidence to
support this course of action. Furthermore, most surgeons admit that they do not comply with
the perioperative antibiotic treatment guidelines followed at their own facility (at hospitals
where the guidelines are based on the EHS recommendations) and they administer antibiotic
prophylaxis to their patients. They explain this by being “profoundly” convinced that they are
doing the right thing [21]
Synthetic mesh has been used since the 1950s to reinforce hernia repair, and in the 1980s
Lichtenstein described a tension free, simple, flat, polypropylene mesh repair for inguinal
hernia. Today, the Lichtenstein’s repair is the most common operation for inguinal hernia in
the developed world. In this surgery wound infection is not uncommon. Many surgeons use
routine prophylactic antibiotics but recent studies suggest little benefit even when mesh is
used. So, it’s role is still not well established as various trials have produced varied results.
These varied results may be due to differences in patient selection criteria, method of
randomisation and follow up of patients.
Yerdel et al in 2001, in their double blind prospective randomised trial used single dose of
ampicillin and sulbactum given just before incision to assess its value in preventing wound
infection in 280 patients undergoing open hernia repair using mesh.
Groups were well matched with all variables. 12 patients in placebo group developed
wound infection. This study documented a significant (10 fold) decrease in overall infection
rate when single dose of antibiotic was used as prophylaxis in Lichenstein hernia repair.
This trail therefore advocated use of antibiotics during hernia repair. However this
data is open to question because of unexpectedly high rates in control group and use of drain
in significant number of patients (27% in antibiotic group and 30% in placebo group).
Aufenaker et al in 2004 did a prospective, double blind randomized multicentre ( involving

4 centres ) study in which they studied 947 patients of which 475 were in prophylactic group
and 472 were in control group. Prophylactic group received single dose of 1.5 g intravenous
cefuroxime. Infection was defined using CDC criteria. Patients were assessed at 1week,
2week and 3 month.
They found 17 patients with infection, of which 8(1.6%) were from antibiotic
prophylaxis group and 9(1.8%) were from placebo group (p = 0.82%). There was 1 deep
infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57).
The results showed that there was no significant difference between the antibiotic
prophylaxis or placebo group in terms of post-operative wound infection, so antibiotic
prophylaxis is not indicated.
The drawback of the study was that the follow up of the patient was not complete as
199 patients missed their 3rd follow up after 12 week and had to be contacted on phone.
Celdran et al in 2004, randomized 99 consecutive hernia repairs to receive 1 g of

parenteral Cefazolin preoperatively or a placebo.
No wound infections existed in the therapeutic group (0/50). Four infections
appeared in the control group 4(8.16%), and the study was suspended for ethical reasons
when differences reached values close to statistical significance (P=0.059).
So they concluded that a single dose of intravenous Cefazolin decreases the risk of
wound infection during open mesh inguinal hernia repair under local anaesthesia on an
ambulatory basis.
However, there is a chance of selection bias in study because method of
randomisation and blinding is not mentioned.
Perez et al in 2005 conducted a prospective, randomized, double-blind, placebo-controlled
trial comparing wound infection rates in 360 patients (180 received prophylactic antibiotics,
180 received a placebo) undergoing primary inguinal hernia repair electively using
polypropylene mesh. Infections were evaluated 1 week, 2 weeks, and 1 month after operation
by an independent surgeon. Results were assessed using chi-square, Fisher’s exact test, and
Student’s t-tests as appropriate.
Superficial surgical site infection developed in 3 patients (1.7%) from the antibiotic
group and 6 (3.3%) from the placebo group (p = 0.50). One from each group developed deep
surgical site infection.
Based on their results they concluded that preoperative administration of single-dose
antibiotic for tension-free inguinal mesh herniorrhaphy did not markedly decrease risk of
wound infection. Their results did not support use of antibiotic prophylaxis for tension-free
mesh herniorrhaphy.
The drawback of the study was, they found that 6 patients from the antibiotic group
and 4 from the placebo group failed to follow-up after the second week.
Tzovaras et al in 2007, did randomised prospective study on 386 patients to have single dose
of amoxicillin and clavulanic acid or placebo in double blind manner. The two groups were
comparable regarding demographic data.
In total 14(3.7%) patients were detected to have wound infections. 5 cases were from
antibiotic group and 9 were from placebo group. The difference was not statistically
significant with p value being 0.4.
Their results showed that antibiotic prophylaxis does not offer any benefits in elective
mesh hernia repair. However they did not mention specific timing of administration of
antibiotic.10
Usang et al in 2008 conducted a prospective study over a period of 8 months from 11 April
2004 to 20 December 2004. During this period, 88 children aged from birth to 15 years were
randomized into two groups of equal numbers to undergo elective inguinal herniotomy. The
children in the test group received prophylactic intravenous gentamicin, 30 min before a
groin crease incision was made, while those in the control group did not.
There were 104 wounds in the ratio of 50:54 in the control and test groups,
respectively. All 54 wounds of the children who received prophylactic gentamicin healed
primarily and without complication. Five cases of wound infections occurred in the control
group, giving an infection rate of 4.8% (P < 0.041). Staphylococcus aureus was the single
pathogen isolated from the infected postherniotomy wounds and this organism was wholly
sensitive to gentamicin.
From the findings in their study they concluded that, administration of preoperative
gentamicin has a role in the prevention of wound infection after day case surgery for inguinal
hernias in susceptible children. They recommended preoperative intravenous gentamicin as a
prophylactic measure against wound infection after day case surgery for inguinal hernias in
those children at risk of wound infection.
However the study included children who are incontinent and therefore often wet,
making them more susceptible to infection.
Sanabria et al in 2007 did a Meta-analysis intended to measure the benefits of antibiotic

prophylaxis on surgical site infection rate in adult patients scheduled for mesh inguinal
hernioplasty. They included 6 randomized clinical trials.
A total of 2507 patients were analysed. Surgical site infection frequency was 17 in
1230 patients (1.38%) in the antibiotic group versus 37 in 1277 (2.89%) in the control group
(odds ratio = 0.48; 95% confidence interval, 0.27– 0.85).
The result indicated, Antibiotic prophylaxis use in patients submitted to mesh inguinal
hernioplasty decreased the rate of surgical site infection by almost 50%.
Mentes et al in 2008 in their study Three hundred and sixty patients were recruited in this
prospective randomized, double blinded placebo controlled study. Patients were divided into
two groups. Group-1 patients were given intravenous 1 g Cefazoline 30 minutes before the
incision, whereas Group-2 patients were given same volume of saline at similar time via
similar route. Surgical site infection was classified as superficial and deep.
There were 3 (1.6%) superficial surgical site infection in Group-1, whereas 5 (2.7%)
in Group-2, postoperatively (p =0.43). Patients with infection were treated by drainage and
antibiotic administration. According to their data, administration of single dose of
prophylactic antibiotic doesn’t decrease the risk of postoperative surgical site infection.
Jain et al in 2008, performed a prospective, randomized double blind control trial of 120
patients with primary unilateral inguinal hernia. This was the first series to study the role of
antibiotic prophylaxis in repair of inguinal hernias using polypropylene mesh system.
Randomisation was done by a computer generated code by a junior resident who was not
involved in surgery, data compilation or patient follow up. The same resident also prepared
the antibiotic or placebo syringes containing normal saline.
Patients in antibiotics group received 1.2g amoxicillin and clavulanic acid. Wounds were
inspected before discharge and all incisions were carefully re-examined at the time of suture
removal, two week after discharge and four week after discharge. In order to remove bias, the
surgeon who performed the operation was not allowed to follow up the patient. Wound
infections were classified by CDC criteria.
One patient in each group developed SSSI. No patient developed DSSI. The infection rate for
both groups was 1.7%. Hence no benefit of routine use of antibiotic prophylaxis in terms of
wound infection rate was found.
Shankar et al in 2010 conducted a prospective, randomized, double-blind, trial comparing

wound infection rates in 450 patients (225 received intravenous Cefazolin, 225 received a
placebo) undergoing primary inguinal hernia repair electively using polypropylene mesh. 334
patients who completed a follow-up period of one month were analysed. CDC criteria were
used to define wound infection. Groups were well matched for all preoperative variables
studied.
The overall infection rate was 8.7% (29 out of 334). The incidence of wound infection
in antibiotic group was 7% and 10.5% in control group (p=0.344). One from each group
developed deep surgical site infection. Most of the infections occurred between the 7th and
12th post-operative day after discharge from the hospital.
Antibiotic prophylaxis was associated with decreased incidence of wound infection
when compared to control group, but the difference was not statistically significant. Based on
their results they did not recommend the routine use of antibiotic prophylaxis in elective
mesh repair of inguinal hernias.
Thakur et al in 2010 conducted a randomized double blind placebo controlled study which
included 55 patients who underwent an inguinal mesh hernioplasty over a 2 year period. The
patients were evaluated for the status of the suture line as well as the presence of wound
infection.
Out of 55 patients 29 were randomized to the antibiotic arm and 26 to the placebo
group. The groups were well matched for all variables studied excluding wound infections,
which occurred at a rate of 10.34% (n = 3) in the antibiotic group and 15.38% (n = 4) in the
placebo arm, (p > 0.01).
Based on above results, this study did not document any statistically significant
difference between those who received antibiotics and those receiving placebo in terms of
any of the prognostic end points evaluated for Lichtenstein mesh hernioplasty.
Goyal et al in 2011performed randomized double blind placebo controlled study which

included a total of 200 patients. Group 1 was given prophylactic dose of intravenous
amoxycilin –clavulanic acid, while group 2 was given placebo. Results were compared and
Data analysed using the Chi-square test.
Complications in both the groups were compared. Rate of serous discharge and
seroma formation was 1% and 22% respectively in group 1 while 2% and 26% in group 2
also the rate of erythema and stitch abscess were 1% and none in group 1 and 2% and 1% in
group 2 respectively.
On statistical analysis these differences were not significant so they concluded that
addition of prophylactic antibiotics in elective open inguinal hernia repair has no significant
benefit over placebo.
But their study lacks well defined criteria to detect wound infection.14
Ergul et al in 2011 assigned patients randomly to either an antibiotic prophylaxis group or a

control group in their prospective randomised control study. Patients in the prophylaxis group
were given 1 g cefazolin by IV bolus injection whereas the placebo control group received an
equal volume of sterile saline preoperatively.
A Lichtenstein repair was done in all cases. The patients were examined for surgical
site infection (SSI) and other postoperative local complications before discharge, and re-
examined 3, 5, 7, and 30 days after discharge. Results Groups were well matched for age,
sex, coexisting diseases, ASA scores, type of hernia, type of anaesthesia, duration of surgery.
Incidence of infection was 7% in the control group (7/100) and 5% in the prophylaxis
group (5/100) (P = 0.38). All the infections were superficial and responded well to drainage
and proper antibiotic therapy. All other postoperative complications were similar in the two
groups.
They concluded that antibiotic prophylaxis has no significant effect on the incidence
of SSI in elective repair of inguinal hernias with mesh. The most effective way to reduce the
incidence of infection in prosthetic repair may be a specific centre for treatment of abdominal
wall hernias.
Hosseini et al in 2011 performed an interventional double blind randomized trial on 212

patients undergoing Lichenstein Inguinal Hernioplasty . total of 100 patients received
prophylactic antibiotic and 112 patients did not receive any antibiotic. They were all
examined by another surgeon on 3,7,14,30 and 60th day postoperatively. Mean age of the
patient was 51.1±4.6.
The incidence of infection in prophylactic group was 2% and in control group was
2.7%, which was not statistically significant (p= 0.4).
So they conclude as ,it is justified to limit the use of antibiotic for therapeutic purpose
and those who have high risk factor for severe infection.
Phanthabordeekorn et al in 2011 conducted a randomized double-blinded placebo-

controlled trial of 106 patients with inguinal hernias. Fifty and 56 patients were allocated to
the intervention and control groups, respectively.
At one-week follow-up, there was no difference of infection rate among the control
and intervention groups. In other words, there was no sign of wound infection found in all of
106 patients. All patients did well without sign of wound infection at one-month follow-up.
Their result showed that there is no clear benefit of preoperative prophylactic
antibiotic for prevention of post inguinal hernioplasty wound infection. For deep surgical site
infection, a longer follow-up at one year is needed for completion of CDC criteria.
Jian-Fang Li et al in 2012 performed a meta-analysis of RCTs studying the use of antibiotic
prophylaxis to prevent postoperative complications in patients undergoing tension-free
hernioplasty.
They included 6 RCTs conducted around the world in their analysis. Compared with
the control condition, antibiotic prophylaxis was associated with a lower incidence of incision
infection (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.26–0.77, p = 0.004). There
were no significant differences in risk for incision hematoma (OR 1.57, 95% CI 0.60–4.10, p
= 0.35), respiratory infection (OR 1.00, 95% CI 0.17–5.79, p > 0.99) or urinary tract infection
(OR 1.81, 95% CI 0.38–8.52, p = 0.45) between the 2 conditions.
Based on above observations they concluded that Antibiotic prophylaxis use in
patients undergoing tension-free hernioplasty decreases the rate of incision infection by 55%.
Rahmani et al in 2012 performed an interventional double-blind randomized trial on 282

patients undergoing, unilateral primary elective inguinal hernioplasty with Lichtenstein
method. They were randomized to receive 1gr/1v cephalothin (keflin) or equal volume of
placebo 30 min before incision. Patients were evaluated 1week, 2weeks and 12weeks after
surgery by an independent surgeon or resident. Wound infection was defined according to the
criteria of centre for Disease control and recorded. Results were assessed using chi-square
and t-test as appropriate.
The total number of wound infection was 13 (4.7%), 4(2.8%) in antibiotic group and
9(6.4%) in placebo group (p= 0.29). There was 1 deep infection only in placebo group.
Statistical analysis showed no significant difference in two groups.
The results show that, in Lichtenstein hernioplasty, routine use of prophylactic
antibiotic is not indicated, as it does not significantly reduce the post-operative surgical site
infection rates.
Yuan yin et al in 2012 performed a metaanalysis of the literature search conducted in

databases of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials.
Study selection, data extraction, quality assessment, and meta-analysis were conducted
according to the recommendations by Cochrane collaboration. Nine randomized controlled
trials were included.
Incidence of surgical site infection was 39/1642 (2.38%) in the antibiotic group and
70/1676 (4.18%) in the control group. Antibiotics showed a protective effect in preventing
SSI after mesh inguinal hernia repair (odds ratio: 0.61, 95% confidence interval: 0.40– 0.92,
I2: 0%).
Based on the results they recommended the use of antibiotic prophylaxis to reduce the
incidence of SSI in hernia patients undergoing mesh hernioplasty. But the cost effectiveness
of antibiotic prophylaxis needs further evaluation.
Aiken et al in 2013 performed a cross-sectional survey of consultant-level general surgeons

in London and the south-east of England on their practices and beliefs regarding antibiotic
prophylaxis in adult elective inguinal hernia repair. Surgeons in training were recruited to
administer the Survey. Local prophylaxis guidelines for the participating hospital sites were
also determined.
The study was conducted at 34 different sites and received completed surveys from
229 out of a possible 245 surgeons, a 93 % response rate. Overall, a large majority of
hospital guidelines (22/28) and surgeons’ personal beliefs (192/229, 84 %) supported the use
of single-dose preoperative intravenous antibiotic prophylaxis in inguinal hernia repair,
although there was considerable variation in the regimens in use. The most widely used
regimen was intravenous co-amoxiclav (1.2 g). Less than half of surgeons were adherent to
their own hospital antibiotic guidelines for this procedure, although many incorrectly
believed that they were following these.
The survey concluded that in the south-east of England, there is a strong majority of
surgical opinion in favour of the use of antibiotic prophylaxis in this procedure. It is therefore
likely to be extremely difficult to conduct further randomised studies in the UK to support or
refute the effectiveness of prophylaxis in this commonly performed procedure
Bidur et al in 2013 randomized patients into 2 groups. Patients with antibiotic prophylaxis
group were administered intravenous antibiotic at the induction of anaesthesia or just before
the incision if operated under local anaesthesia (group 1); patients with no antibiotic
prophylaxis group were administered sterile normal saline intravenously at the same time
(group 2). After Lichtenstein inguinal hernioplasty, patients were followed up twice at 7-9
days and 28-42 days to assess surgical site infection, persistent pain, chronic sinus, testicular
atrophy and recurrence if any as final outcome of treatment.
Total of sixty patients (59 male and 1 female), thirty in each group were enrolled.
During the first follow up, 1 patient (3.3%) developed wound infection from group 2 whereas
none of the patients developed wound infection (0%) from group 1. During the second follow
up, none of the patients from both the groups had any complication.
Their study showed that there is no benefit of intravenous single dose antibiotic
prophylaxis in the prevention of wound infection following Lichtenstein inguinal
hernioplasty in patients with no other co-morbid conditions.
Sasika javi et al in 2013 conducted an open label randomized clinical trial. The target
population was all patients who underwent tension-free hernioplasty. The acquired data was
analysed after an independent t test was performed. Mann-Whitney U test, Fisher’s exact test,
and Two-Sample Kolmogorov-Smirnov test were used to determine the correlations between
variables, where p < 0.05 was regardless of significant.
From 54 subjects 3 (5.6%) of them were found to have a slight erythema around the
operation wound, on the 7th,14th,21th, and 28th day no signs of erythema were found. From
the three subjects two (7.4%) were from the placebo group and one (3.7%) from the antibiotic
group. All clinical assessment of post-operative wound was made using Southampton Wound
Assessment Scale, where erythema is a grade 1C, all subjects healed primarily.
They found no significant difference in patients who were given prophylactic
antibiotics and placebo in terms of SSI.
Ullah et al in 2013 et al carried out prospective randomised controlled trial in which the
patients were randomly divided into two groups. Patients in group A were given a single dose
of antibiotic before inguinal hernia mesh repair and patients in group B were given placebo
before inguinal hernia mesh repair. Efficacy of antibiotic and placebo was accessed in terms
of surgical site infections (SSIs).
A total of 166 cases of inguinal hernia mesh repair patients were recorded during the
study period. A total of 83 patients were recruited in each group. Surgical site infection was
found in 6 (7.2%)patients in antibiotic group while in placebo group it was 15 (18.1%).
The difference being statistically significant (p=0.036). Their study supported use of
Antibiotic prophylaxis for hernioplasty.
Wang at al in 2013 performed a prospective randomized, double-blind, placebo controlled
trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair.
A total of 1,200 cases with primary inguinal hernia treated in 6 hospitals in Shaanxi Province
were enrolled in this study. They were randomly divided into three groups (n = 400 per
group): placebo control group, Cefazolin group and Levofloxacin group after tensionfree
inguinal hernia repair using polypropylene mesh. Hernia type, age, gender, weight and
complications were recorded. The surgical-site infection was diagnosed according to CDC
criteria. Infections were evaluated every other day in the first week, and then at 14 days, 21
days and 30 days following surgery.
The data of the 1,160 cases were statistically analyzed in the incidence rates of
surgical-site infection and complications after inguinal hernia repair. Surgical-site infection
including wound infection, cellulitis or mesh-related infection was found in 20 cases (5.1%)
of the control group, 15 (3.92%) of the Cefazolin group and 17 (4.42%) of the Levofloxacin
group, and the difference among the three groups was not statistically significant (χ2 = 0.438,
p = 0.803). There was also no significant difference in post-surgery complications including
seroma (p = 0.6366), urinary retention (p = 0.8136), fat liquefaction (p = 0.8061), pulmonary
infection (p = 0.1911), and urinary tract infection (p = 0.8144) among the three groups.
This study concluded that prophylactic use of Cefazolin or Levofloxacin did not
significantly decrease the risk of wound infection in these patients undergoing inguinal hernia
repair. The results do not support the administration of antibiotic prophylaxis for tension-free
inguinal hernia repair.
Kochhar et al in 2014 performed double-blind randomised control trial involving two

hundred and seventeen patients with inguinal hernia undergoing elective Lichtenstein repair.
The study population was randomized in two groups. The study group was administered
parenteral amoxicilin–clavulanic acid while the control group received placebo
preoperatively.
The rate of infection was 3.77% and 4.72% in the study and control groups,
respectively. There was no statistically significant difference in the infection rates between
the two groups. This did not indicate any advantage of antibiotic prophylaxis in elective
Lichtenstein mesh hernia repair in terms of infectious complications.
So, the use of antibiotic prophylaxis is not recommended, as it may lead to bacterial
resistance and a significant economic impact.
Mazaki et al in 2014 conducted a double-blind, randomized, placebo-controlled trial.
Patients who underwent elective open mesh-plug hernia repair were eligible for
randomization. In the antibiotic prophylaxis group, 1.0 g cefazolin was intravenously
administrated 30 minutes before the incision. In the placebo group, an equal volume of sterile
saline was administered. The primary end point was the incidence of SSI.
A total of 200 patients were enrolled. SSI developed in 2 of 100 patients (2%) in the
antibiotic prophylaxis group and 13 of 100 patients (13%) in the placebo group, indicating a
significant difference between the 2 groups (relative risk ratio, 0.25; 95% confidence interval,
0.070 to 0.92; P = .003). Other complications occurred in 23 patients: 7 (7%) in the antibiotic
prophylaxis group and 16 (16%) in the placebo group (P = .046).
This study indicates that antibiotic prophylaxis is effective for the prevention of SSI
after open mesh-plug hernia repair.
Othman et al in 2015 et al performed randomized double-blinded placebo-controlled trial

after having permission from the Ethical Review Board of the hospital. 106 patients with
inguinal hernias, American Society of Anaesthesiologists (ASA) Class 1-2, who never had
allergy to cephalosporin and aged over 18 years-old were included. 50 and 56 patients were
allocated to the intervention and control groups, respectively.
At one-week follow-up, there was no difference of infection rate among the control
and intervention groups. In other words, there was no sign of wound infection found in all of
106 patients. All patients did well without sign of wound infection at one-month follow-up.
Their study indicated no clear benefit of preoperative prophylactic antibiotic for
prevention of post inguinal hernioplasty wound infection. For deep surgical site infection, a
longer follow-up at one year is needed for completion of CDC criteria.
Vinoth et al in 2015 et al conducted a randomized double-blinded placebo-controlled trial in

which 60 patients were included. 30 of them received 1 g of injection cefotaxime half hour
before surgery and remaining 30 received Multivitamin infusion. Lichtenstein tension free
hernia repair using polypropylene mesh was done. Superficial SSI was diagnosed according
to CDC criteria.
Totally 5 patients developed SSI (8.33%). Out of the five, 2(6.67%) were in antibiotic
group and remaining 3 (10%) were in placebo (p=0.64). All 5 had only superficial SSI. 2
patients were managed with dressing alone and remaining 3 with antibiotics. After 2 weeks 2
had wound gaping and at four weeks wound was normal in all patients. 2 out of 5 were above
60 years of age and no SSI occurred >30 years of age (p value = 0.59).
As a conclusion of the study they recommended that routine use of antibiotics is not
necessary in all open inguinal hernioplasty. Antibiotics can be reserved only for patients who
are in high risk of SSI. Regularizing the use of antibiotics will have a good cost benefit and
decrease the emergence of drug resistant organisms.
Ketan Kapoor et al in 2015 did a randomized double blind placebo-controlled trial 200
patients were included in the study and the study population was randomized in two groups.
The study group was administered parenteral cefazolin while the control group received
placebo preoperatively. Follow up was done for 30 days post-surgery which included 180
patients.
The overall infection rate was 8.3% (15 out of 180). The incidence of wound infection
in antibiotic group was 7(7.4%) and 8(9.3%) in control group(p=0.351). There was no
statistically significant difference in the infection rates between the two groups.
In their study they concluded as, antibiotics showed a protective effect in preventing
SSI after mesh inguinal hernia repair. However significant values cannot be obtained and cost
effectiveness of antibiotic prophylaxis needs further evaluation. Therefore routine use is not
recommended.
Zhuo et al in 2016 performed a retrospective observational study to know the efficacy of

routine antibiotic prophylaxis for prevention of surgical site infection (SSI) after elective
inguinal hernia repair with a mesh patch.
All low-risk patients who underwent elective inguinal hernia repair with mesh at their
institution between 2010 and 2015 were enrolled in this study, with the exception of patients
with recurrent hernias or immunosuppressive diseases. All patients received a single
intravenous (i.v.) injection of cefuroxime (1.5 g) within 2 h prior to surgery at the discretion
of the surgeon. SSI was defined using criteria of the Centers for Disease Control and
Prevention. The variables which could influence the rate of SSI were analyzed by
multivariate analysis to determine the independent risk factors for SSI.
Among the 605 patients who underwent elective inguinal hernia repair with mesh
during the study period, 553 were eligible for enrolment in the study. Of these, 331 received a
single dose of cefuroxime preoperatively. The overall SSI rate was 5.4 %; 9.4 % of those
patients who did not receive preoperative antibiotic prophylaxis developed SSI versus 2.8 %
of those who did receive prophylaxis (P = 0.001). All infections were superficial. Factors
independently associated with SSI were advanced age, smoking and preoperative stay.
They concluded that the incidence of SSI among low-risk patients who did and did
not receive preoperative antibiotic prophylaxis after elective inguinal hernia repair with mesh
differed significantly, particularly among patients of advanced age, smokers and patients with
a prolonged preoperative stay in the hospital.
Gauri Shankar et al in 2017 conducted a randomized double blind control trial designed to
study the efficacy of antibiotic prophylaxis in preventing SSI (surgical site infection) in
patients undergoing Lichenstein’s hernioplasty at a tertiary care centre.
The overall SSI incidence was found to be 12% in the study population. Among the
placebo group, SSI was observed in 7 patients (14%). In the patients in whom antibiotic
prophylaxis was administered, SSI was observed in 5 patients (10%).
Antibiotic prophylaxis was associated with decreased incidence of wound infection
when compared to control group, but the difference was not statistically significant (p=0.53).
Boonchan et al did 2017 a meta-analysis of RCTs that have compared efficacy of antibiotic
prophylaxis on SSI after inguinal or femoral hernia repair from PubMed and Scopus
databases up to March 2016. Data were extracted independently by two reviewers. Network
meta-analysis was applied to assess treatment efficacy. The probability of being the best
antibiotic prophylaxis was estimated using surface under the cumulative ranking curve
(SUCRA) analysis.
Fifteen RCTs (5159 patients) met the inclusion criteria. Interventions were first-
generation (7 RCTs, 1237 patients) and second-generation (2 RCTs, 532) cephalosporins, 𝛃-
lactam/𝛃-lactamase inhibitors (6 RCTs, 619) and fluoroquinolones (2 RCTs, 581), with
placebo as the most common comparator (14 RCTs, 2190).
A network meta-analysis showed that 𝛃-lactam/𝛃-lactamase inhibitors and first-
generation cephalosporins were significantly superior to placebo, with a pooled risk ratio of
0⋅44 (95 per cent c.i. 0⋅25 to 0⋅75) and 0⋅62 (0⋅42 to 0⋅92) respectively. However, none of the
antibiotic classes was significantly different from the others.
SUCRA results concluded that 𝛃-lactam/𝛃-lactamase inhibitors and first-generation
cephalosporins were ranked first and second respectively for most effective prophylaxis for
adult patients undergoing groin hernia repair and were significantly superior to placebo.
Sethi 2017 et al performed a prospective, randomised study on 60 patients of inguinal hernia

(either direct or indirect). All patients were operated on an elective basis. Group I (Study
group) included 30 patients in whom single dose of prophylactic cefazolin 1g was given
preoperatively and Group II (Control group) included 30 patients in whom no antibiotic was
given preoperatively.
The participants in the study were all males with the mean age of presentation being
43.60 years. In thirty nine patients (65%) Lichtenstein repair was done for indirect inguinal
hernias, seventeen patients (28.33%) underwent Lichtenstein repair along with plication of
posterior wall. Maximum number of cases were of indirect inguinal hernia 32 (53.33%), two
(3.33%) had inguinal hernia with retractile testis. The average duration of surgery in their
study was 49 minutes. In this study the incidence of SSI in the antibiotic group was 3.33%
and the incidence of SSI in the control group was also 3.33% (p=1) indicating that the
difference is not significant.
The results of this study demonstrates that good preoperative care like patient taking
bath before surgery, shaving just before the surgery, standard cleaning of the parts with 10 %
povidone iodine solution, draping, meticulous surgical technique, ensuring haemostasis,
closing the wound in layers and early discharge of the patient on the next day helps in
preventing the surgical site infection.
MacCormick et al in 2018 conducted Survey Monkey of general surgeons and senior

surgical trainees via the local trust network and the questionnaire was displayed on the
website of the Association of Surgeons of Great Britain and Ireland and Association of
Surgeons in Training.
Eighty-one responses were received from surgeons who perform an average of 75
hernia repairs per year – the majority by open technique. Thirty-six (44.4%) used routine
antibiotic prophylaxis, 40 (49.4%) selectively, and five (6.2%) not at all. The five surgeons
who did not use antibiotics perceived their surgical site infection rate to be <1% and have
never removed an infected mesh from a hernia wound. There was no clear difference between
those who use prophylactic antibiotics routinely or selectively as the experience of mesh
explantation is similar (56% versus 55% had 2–10 meshes removed respectively). Seventy-
seven (95%) of surgeons felt a new specific set of guidelines was required.
This study highlights the fact that in the absence of clear guidelines, most surgeons
base their use of prophylactic antibiotics on their perceived risk or experience of surgical site
infection. There is a strong need for a new set of guidelines to address the use of prophylactic
antibiotics in groin hernia surgery.
Boonchan et al performed network meta-analysis of antibiotic prophylaxis for prevention of

surgical-site infection after groin hernia surgery to compare the efficacy of different antibiotic
classes for prevention of surgical-site infection (SSI) after hernia repair.
RCTs were identified that compared efficacy of antibiotic prophylaxis on SSI after
inguinalor femoral hernia repair from PubMed and Scopus databases up to March 2016. Data
were extracted independently by two reviewers. Network meta-analysis was applied to assess
treatment efficacy. The probability of being the best antibiotic prophylaxis was estimated
using surface under the cumulative ranking curve (SUCRA) analysis.
Fifteen RCTs (5159 patients) met the inclusion criteria. Interventions were first-
generation (7 RCTs, 1237 patients) and second-generation (2 RCTs, 532) cephalosporins, 𝛃-
lactam/𝛃-lactamase inhibitors (6 RCTs, 619) and fluoroquinolones (2 RCTs, 581), with
placebo as the most common comparator (14 RCTs, 2190). A network meta-analysis showed
that 𝛃 lactam/𝛃-lactamase inhibitors and first-generation cephalosporins were significantly
superior to placebo, with a pooled risk ratio of 0⋅44 (95 per cent c.i. 0⋅25 to 0⋅75) and 0⋅62
(0⋅42 to 0⋅92) respectively. However, none of the antibiotic classes was significantly different
from the others. SUCRA results indicated that 𝛃-lactam/𝛃-lactamase inhibitors and first-
generation cephalosporins were ranked first and second respectively for best prophylaxis. 𝛃-
Lactam/𝛃-lactamase inhibitors followed by first-generation cephalosporins ranked as the
most effective SSI prophylaxis for adult patients undergoing groin hernia repair
Sanabria et al in their meta-analysis on the prophylactic use of antibiotic in mesh hernia

repair assessed six randomized controlled trials using the Cochrane inclusion criteria and
concluded that antibiotic prophylaxis decreased the rate of surgical site infection almost by
50%.
Jhang et al performed a meta-analysis of RCTs studying the use of antibiotic prophylaxis to
prevent postoperative complications in patients undergoing tension-free hernioplasty. They
included 6 RCTs conducted around the world in their analysis. Compared with the control
condition, antibiotic prophylaxis was associated with a lower incidence of incision infection
(odds ratio [OR] 0.45, 95% confidence interval [CI] 0.26– 0.77, p = 0.004). They concluded
antibiotic prophylaxis use in patients undergoing tension-free hernioplasty decreases the rate
of incision infection by 55%.
Yuan et al did a literature search in databases of MEDLINE, EMBASE, and Cochrane

Central Register of Controlled Trials. Study selection, data extraction, quality assessment,
and meta-analysis were conducted according to the recommendations by Cochrane
collaboration. Nine randomized controlled trials were included. Incidence of surgical site
infection was 39/1642 (2.38%) in the antibiotic group and 70/1676 (4.18%) in the control
group. Antibiotics showed a protective effect in preventing SSI after mesh inguinal hernia
repair (odds ratio: 0.61, 95% confidence interval: 0.40– 0.92, I2: 0%).
On the other hand a Cochrane review conducted my Sanchez- Manuel and Seco-Gil 2006,
included 8 RCTs in which 3 series used mesh and the remaining did not. Based on the results
in 2,907 patients the authors concluded that there was no clear evidence suggesting routine
use of antibiotics in elective hernia surgery.
the results of RCTs to assess the use of prophylaxis in hernia repair procedures are
inconclusive [……………….]. ………………. trials are in favour of using prophylaxis
[……….., while ………..are against [………].
LACUNAE IN LITERATURE:
Findings of research in the literature show controversies about the use of prophylactic
antibiotic in tension free open mesh repair of primary inguinal hernia.
.
Infection Infection
Sr. Auther Year of Antibiotic in Placebo in P
No. study group antibiotic group placebo value SSSI DSSI
group group
Our
57 4 57 5 0.728
study
Sethi et 1 1
1 2017 30 30
al (3.33%) (3.33%)
Gowri
5 7
2 Sankar 2017 50 50 0.53
(10%) (14%)
et al
Kocchar 4 5
3 2014 106 106 0.708
et al (3.77%) (4.72%)
Vinoth et 2 3
4 2015 30 30 0.64
al (6.67%) (10%)
Razack 7 15
5 2015 94 86 0.351
et al (7.4%) (9.3%)
1
6 KC B et 2013 30 0 30 0.365
(3.3%)
al
Saskia-
1 2
7 Javi 2013 27 27
(3.7%) (7.4%)
et al
Rahmani 4 9
8 2012 141 141 0.29
et al (2.8%) (6.4%)
Phanthab
ord-
9 2011 56 0 56 0
eekorn et
al
Hosseini 2 3
10 2011 100 112 0.4
et al (2%) (2.7%)
11 2010 29 3 26 4
Thakur (10.34%) (15.34%)
et al
Mentes 3 5
12 2008 180 180 0.43
et al (1.6%) (2.7%)
Zhuo et 9 21 30(3.7
13 2016 331 222 0.001 0
al (2.8%) (9.4%) %)
Mazaki 2 13
14 2013 100 100 0.003 NR NR
et al (2%) (13%)
Ullah et 6 15
15 2013 83 83 0.036 NR NR
al (7.2%) (18.1%)
Amit et 1 3 3(1.5% 1(0.5%

16 2011 100 100 0.33
al (1%) (3%) ) )
Othman 4 6
17 2011 50 48 0.47 8(8%) 2(2%)
et al (2%) (2.8%)
Ergul et 5 7 12
18 2011 100 100 0.38 0(0%)
al (5%) (7%) (6%)
Shankar 12 17 27 2(0.4%
19 2010 225 225 0.344
et al (7%) (10.5%) (6%) )
Usang et 5
20 2008 44 0 44 0.041 NR NR
al (4.8%)
1 1 2(3.4%
21 Jain et al 2008 60 60 0.50 0(0%)
(1.7%) (1.7%) )
Tzovaras 5 9 14(3.6
22 2006 193 193 0.40 0(0%)
et al (2.5%) (4.6%) %)
Perez et 3 6 7(1.9% 2(0.5%

23 2005 180 180 0.50
al (1.7%) (3.3%) ) )
24 Oteiza 2004 124 1 123 0
Celdran 4
25 2004 50 0 49 0.05 4(4%) 0(0%)
et al (8.16%)
Aufenac 8 9 14(1.4 3(0.3

26 2004 475 472 0.82
ker et al (1.6%) (1.8%) %) %)
Yerdel et 1 12 4
27 2001 136 133 .0015 9 (3% )
al (0.9%) (9%) (1.4%)
4 6
28 Morales 2000 237 287
(1.7%) (2.09%)
Infection
Sr. Infection
Auther Year of Antibiotic in Placebo P
No in placebo
study group antibiotic group value
group
group
Sethi et 1 1
1 2017 30 30
al (3.33%) (3.33%)
Alagarsa 5 7
2 2017 50 50 0.53
my et al (10%) (14%)
Kocchar 4 5
3 2014 106 106 0.708
et al (3.77%) (4.72%)
Vinoth et 2 3
4 2015 30 30 0.64
al (6.67%) (10%)
Thakur 3 4
5 2010 29 26
et al (10.34%) (15.34%)
Amit et 1 3
6 2011 100 100 0.33
al (1%) (3%)
Shankar 12 17
7 2010 225 225 0.344
et al (7%) (10.5%)
1 1
8 Jain et al 2008 60 60 0.50
(1.7%) (1.7%)
MATERIAL AND METHOD
Study site:
All patients admitted to indoor of department of general surgery, Ispat General
Hospital, Rourkela with diagnosis of Primary Inguinal Hernia.
Study population:
Patients of both sex and age above 18 years admitted to Ispat General Hospital,
Rourkela for elective inguinal hernia open mesh repair.
Study design:
Randomised Prospective Double Blind Placebo controlled study.
There were 2 groups, named as antibiotic group (receiving single dose of
antibiotic during induction of anesthesia) and control group (receiving similar
amount of normal saline as placebo). Patients were allocated in to 2 groups
randomly as mentioned below. There were 114 opaque envelopes each
containing a random number from random number table. The last digit of the
numbers was considered. 0 to 4 was used for antibiotic group and 5 to 9 was
used for control group. The numbers were written and sealed in the envelopes.
These were opened just before operation by the operating surgeon.
When a patient was randomized to the no drain group but the operative situation demands the
use of a drain, the same was placed in the sub hepatic space but the patient was excluded
from the study.
SAMPLE SIZE:
As per the past records from our departmental register I have found out that the
no. of patients undergoing inguinal hernia open mesh repair is about 124 per
year at our centre. As my study period was of one and half year this came
around 186. After applying my study exclusion criteria my population size was
assumed to be 160.
Keeping the confidence interval 5% and confidence level of 95%, by applying
sample size calculator software from http://www.raosoft.com/samplesize.html,
the sample size for my study came as 114.
The equation used is mentioned below, where N is the population size, r is the
fraction of responses, and Z(c/100) is the critical value for the confidence level
c, sample size is n and margin of error is E.
x = Z(c/100)2r(100-r)
n = N x/[(N-1)E2 + x]
E = Sqrt [(N - n)x/n(N-1)]
Study period:
August 2016 to February 2018.
Inclusion criteria:
All patients admitted to Ispat General Hospital, Rourkela for elective open mesh
repair of primary inguinal hernia.
Exclusion criteria:
1. Patients with recurrent, irreducible, strangulated, bilateral, femoral hernia.
2. Evidence of systemic disease (e.g. renal or liver impairment, diabetes).
3. History of antibiotic allergy.
4. Immune-compromised patients.
5. Patients who are not willing for follow up.
6. Patients with age less than 18 years.
7. Patients with local skin infection or disease at the site of incision.
8. Patients who were using or had used antibiotics less than a week before
surgery.
9. Patients taking steroids for any reason.
MATERIAL:
1. 1.2 g of Amoxicillin and clavulanic acid combination as antibiotics and
normal saline as placebo.
2. Surgical instruments for open mesh repair --
 Syringe
 25-Gauge needle
 Mosquito forceps
 Surgical knife with blade
 Dissecting scissors
 Polypropylene or polyester mesh
 Langenbeck retractors
 Needle holder
 Sutures (absorbable or non-absorbable)
3. Routine laboratory values (TLC, DLC).
Methodology:
Clearance required from research and ethical committee was obtained before
starting the study.
All patients planned for inguinal hernia repair were admitted one day before
surgery. Informed consent was taken from all patients. Patients undergone
normal routine detailed clinical history, examination. After enrolling the
patients, following investigations were done.
Preoperative workup
1. complete haemogram,
2. renal function tests,
3. liver function tests,
4. coagulation profile,
5. urine routine and microscopy,
6. chest X- ray
7. ECG.
Patients were allocated in to two groups randomly by using the method

described in the study design section.
Group 1: Broad spectrum antibiotic intravenous 1.2 gm of amoxicillin and
clavulanic acid combination in 20 ml of sterile saline was used and given by
anaesthetist at the time of administration of anaesthesia for patients in antibiotic
group.
Group 2: Similar amount of Normal saline was used as placebo. The patient,
operating surgeon and anaesthetist were blinded during randomization.
Surgery was performed under spinal anaesthesia
All surgeries were performed by same surgeon who have performed more than
500 cases as per standard steps of lichtenstein’s tension free open mesh repair of
inguinal hernia.
Steps of surgery
1. All the patients were advised to take bath with soap and water early in the
morning on the day of surgery.
2. Shaving of the surgical site done before entering in to operation theatre.
3. Content of the hernia reduced.
4. Skin was prepared at the surgical site immediately before the incision
using 10% povidone iodine solution.
5. Four layers of coating was done, this was followed by draping the
patients with sterile surgical sheets and then cleaned by spirit.
6. Around 4 to 5 cm skin incision, within the Langer line, around 1 cm
above and parallel to inguinal ligament given to have adequate access to
the pubic tubercle and the internal ring.
7. After skin incision, the external oblique aponeurosis was opened and its
lower leaf was freed from the spermatic cod.
8. The upper leaf of the external oblique was then freed from the underlying
internal oblique muscle until the internal oblique aponeurosis was
exposed.
9. The cord with its cremaster covering was separated from the floor of the
inguinal canal and the pubic bone for distance of approximately 2 cm
beyond the pubic tubercle.
10.Opening of the coverings of the spermatic cord and identification and
isolation of the hernia sac.
11.Inversion, division, resection, or ligation of the sac, was done as

indicated.
12.Monofilament polypropylene mesh was tailored to its standard shape,

which resembled the tracing of a footprint, with a lower sharper angle to
fit into the angle between the inguinal ligament and the rectus sheath and
an upper wider angle to spread over the rectus sheath.
13.A slit was made at the lateral end of the mesh, creating two tails, a wide
one (two thirds) above and a narrower one (one-third) below.
14.The cord retracted upward, the sharper corner was sutured with a non-
absorbable monofilament suture material to the insertion of the rectus
sheath to the pubic bone and overlapping the bone by 1 to 2 cm. This
suture was continued (as a continuous suture with up to four passages) to
attach the lower edge of the patch to the inguinal ligament upto a point
just lateral to the internal ring.
15.The wider upper tail was grasped with forceps and passed towards the
head of the patient from underneath the spermatic cord; this positioned
the cord between the two tails of the mesh.
16.The upper edge of the patch was sutured in place with two interrupted
absorbable sutures, one to the rectus sheath and the other to the internal
oblique aponeurosis, just lateral to the internal ring.
17.Using a single non-absorbable monofilament suture, the lower edges of

each of the two tails was fixed to the inguinal ligament just lateral to the
completion knot of the lower running suture.
18.This created a new internal ring made of mesh. The excess patch on the
lateral side was trimmed, leaving at least 5 cm of mesh beyond the
internal ring.
19.This tucked underneath the external oblique aponeurosis, which then

closed over the cord with an absorbable suture.
20.Subcutaneous tissue, and the skin closed in layers.
21.Incision line cleaned with betadine solution and then dressing was done
using gauge with scrotal support.
22.No postoperative antibiotics were used. Analgesics were used sos.
23.Surgical site was examined after 48 hours of surgery.
24.Patients were discharged to revisit as follow-up after one week for wound
assessment and suture removal.
Follow up:
All patients were educated about the symptoms and signs of surgical site
infections and were instructed to report to us in case they developed any such
symptoms and signs.
All wounds were assessed at the time of discharge (48 hours after surgery)
and re-examined at time of suture removal (7 days after operation), two week
after discharge and four week after discharge by a surgeon who did not know
whether the patient was belonging to control group or antibiotic group.
Southampton grading system was used to asses post-operative wound.
SOUTHAMPTON WOUND GRADING SYSTEM
GRADE APPEARANCE
0 NORMAL HEALING
NORMAL HEALING a. Some Bruising

I. WITH MILD
b. Considerable Bruising
BRUISING OR
ERYTHEMA c. Mild Erythema
a. At One Point
ERYTHEMA PLUS
b. Around Sutures
II. OTHER SIGNS OF
c. Along Wound
INFLAMATION
d. Around Wound
a. At One Point (≤2cm)

CLEAR OR
b. Along Wound(>2cm)
III. HEMOSEROUS
c. Large Volume
DISCHARGE
d. Prolonged(>3days)
a. At One Point (≤2cm)

IV. PUS
b. Along Wound(>2cm)
DEEP OR SEVERE DEEP INFECTION

V. WITH OR WITHOUT TISSUE BREAKDOWN;
HEMATOMA REQUIRING ASPIRATION
Wound infections were classified as per the CDC (Centre for Disease
Control) criteria as superficial SSI and deep SSI.
SUPERFICIAL INCISIONAL SSI
1. Date of event for infection occurs within 30 days after any NHSN operative procedure
(where day 1 = the procedure date).
AND
2. Infection involves only skin and subcutaneous tissue of the incision.
AND
a) Purulent drainage from the superficial incision.
b) Organisms identified from an aseptically-obtained specimen from the superficial
incision or subcutaneous tissue by a culture or non-culture based microbiologic
testing method which is performed for purposes of clinical diagnosis or treatment
(for example, not active surveillance culture/testing (asc/ast).
c) Superficial incision that is deliberately opened by a surgeon, attending
physician** or other designee and culture or non-culture based testing is not
performed.
AND
Patient has at least one of the following signs or symptoms: pain or tenderness;
localized swelling; erythema; or heat.
d) Diagnosis of a superficial incisional SSI by the surgeon or attending physician**
or other designee.
** The term attending physician for the purposes of application of the NHSN SSI criteria
may be interpreted to mean the surgeon(s), infectious disease, other physician on the case,
emergency physician or physician’s designee (nurse practitioner or physician’s assistant).
DEEP INCISIONAL SSI

1) The date of event for infection occurs within 30 or 90 days after the NHSN operative
procedure (where day 1 = the procedure date)
AND
2) Infection involves deep soft tissues of the incision (for example, fascial and muscle
layers)
AND
3) patient has at least one of the following:
a) Purulent drainage from the deep incision.
b) A deep incision that spontaneously dehisces, or is deliberately opened or aspirated
by surgeon, attending physician** or other designee
AND
Organism is identified by a culture or non-culture based microbiologic testing
method which is performed for purposes of clinical diagnosis or treatment (for
example, not Active Surveillance Culture/Testing (ASC/AST) or culture or non
culture based microbiologic testing method is not performed.
AND
Patient has at least one of the following signs or symptoms: fever (>38°C);
localized pain or tenderness.
c) An abscess or other evidence of infection involving the deep incision that is
detected on gross anatomical or histopathologic exam, or imaging test.
d) Diagnosis of a deep incisional SSI by the surgeon or attending physician or other
designee.
Statistical analysis:
Descriptive and inferential statistical analysis has been carried out in the present
study. Results on continuous measurements are presented on Mean  SD (Min-Max) and
results on categorical measurements are presented in Number (%). Significance is assessed at
5 % level of significance. The following assumptions on data are made, Assumptions:
1.Dependent variables should be normally distributed, 2.Samples drawn from the population
should be random, cases of the samples should be independent.
Student t test (two tailed, independent) has been used to find the significance of study
parameters on continuous scale between two groups (Inter group analysis) on metric
parameters. Leven1s test for homogeneity of variance has been performed to assess the
homogeneity of variance
Chi-square/ Fisher Exact test has been used to find the significance of study parameters on
categorical scale between two or more groups, Non-parametric setting for Qualitative data
analysis. Fisher Exact test used when cell samples are very small.
Significant figures
+ Suggestive significance (P value: 0.05<P<0.10)

* Moderately significant (P value:0.01<P  0.05)
** Strongly significant (P value: P0.01)
Statistical software: The Statistical software namely SPSS 18.0, and R environment
ver.3.2.2 were used for the analysis of the data and Microsoft word and Excel have been used
to generate graphs, tables etc.
RESULTS
Table 1: Age distribution of patients studied
Age in Antibiotic Placebo

Total
years Group group
21-30 11(19.3%) 6(10.5%) 17(14.9%)
31-40 15(26.3%) 13(22.8%) 28(24.6%)
41-50 14(24.6%) 19(33.3%) 33(28.9%)
51-60 13(22.8%) 15(26.3%) 28(24.6%)
61-70 4(7%) 4(7%) 8(7%)
Total 57(100%) 57(100%) 114(100%)
Mean ± SD 42.67±11.67 45.37±10.65 44.02±11.20
Samples are age matched with P=0.199,

Statistical test used - student t test
35 Antibiotic Group
30 Placebo group
25
Percentage
20
15
10
0
21-30 31-40 41-50 51-60 61-70
Axis Title
In our study, antibiotic and placebo groups were matched with respect to the age of the
patient with mean age in antibiotic group being 42.67±11.67 and that of in placebo group
being 45.37±10.65. Maximum numbers of patient were in 41-50 years of age group, mean
age of presentation being 44.02±11.20. Youngest patient was of 22 years old male and oldest
patient was 65 years old male.
Table 2: Gender distribution of patients studied
Antibiotic Placebo
Gender Total
Group group
Male 57(100%) 57(100%) 114(100%)
Female 0(0%) 0(0%) 0(0%)
Total 57(100%) 57(100%) 114(100%)
P=1.000, Not Significant,

Statistical test used - Fisher Exact Test
Antibiotic Group
100 Placebo group
80
Percentage
60
40
20
0
Male Female
Gender
All patients in this study population were male (n=116, 100%) cases. We did not encounter
any female patient.
Table 3: Side distribution in two groups of patients studied
Antibiotic Placebo
Side Total
Group group
Left 24(42.1%) 27(47.4%) 51(44.7%)
Right 33(57.9%) 30(52.6%) 63(55.3%)
Total 57(100%) 57(100%) 114(100%)

Statistical test used - Chi-Square test
Antibiotic Group
60
Placebo group
50
40
Percentage
30
20
10
0
Left Right
Side of Hernia
In our study, in the antibiotic group 24(42.1%) patients had left sided hernia and 33(57.9%)
patients had right sided hernia. , while in the placebo group 27(47.4%) patients had left sided
hernia and 30(52.6%) patients had right sided hernia. Out of total population, 51(44.7%)
patients had left sided hernia and 63(55.3%) had right sided hernia. When analyzed with
respect to the type of hernia, both groups have statistically insignificant difference (P=0.833)
Table 4: Type distribution in two groups of patients studied
Antibiotic Placebo
Type Total
Group group
Direct 15(26.3%) 16(28.1%) 31(27.2%)
Indirect 42(73.7%) 41(71.9%) 83(72.8%)
Total 57(100%) 57(100%) 114(100%)

Antibiotic Group
Placebo group
80
60
Percentage
40
20
0
Direct Indirect
Type of Hernia
When analyzed with respect to the type of hernia, both groups have statistically insignificant
difference (P=0.833). The antibiotic group had 42(73.7%) patients with an indirect hernia and
15(26.3%) patients with direct hernia. The placebo group had 41(71.9%) patients with an
indirect hernia and 16(28.1%) patients with direct hernia. Overall 83(72.8%) patients had an
indirect hernia and 31(27.2%) had direct hernia.
Table 5: Overall infection distribution in two groups of patients
Antibiotic Placebo
Total
Infection Group group
(n=114)
(n=57) (n=57)
Overall
Infections
 No 53(92.9%) 52(91.2%) 105(92.1%)
0.728
 Yes 4(7.1%) 5(8.8%) 9(7.9%)

Overall Infections
100 No
90 Yes
80
70
Percentage
60
50
40
30
20
10
0
Antibiotic Group(n=57) Placebo group(n=57)
The incidence of SSI was analyzed in both the groups, 4(7.1%) patients in antibiotic group
and 5(8.8%) patients in placebo group had features of SSI. There was no statistically
significant difference in antibiotic and placebo group (p=0.728).
Table 6: Infection distribution in two groups of patients studied at discharge
Antibiotic Placebo
Total
Infection Group group P value
(n=114)
(n=57) (n=57)
At Discharge
 No 57(100%) 57(100%) 114(100%)
1.000
 Yes 0(0%) 0(0%) 0(0%)

At Discharge
100 No
90 Yes
80
70
Percentage
60
50
40
30
20
10
0
No patient in both antibiotic as well as placebo group showed features of SSI at the time of
discharge.
Table 7: Infection distribution in two groups of patients at suture removal
Antibiotic Placebo
Total
(n=114)
(n=57) (n=57)
At Suture
removal
 No 56(98.2%) 56(98.2%) 112(98.2%)
1.000
 Yes 1(1.8%) 1(1.8%) 2(1.8%)

At Suture removal
100 No
90 Yes
80
70
Percentage
60
50
40
30
20
10
0
1(1.8%) patient from each antibiotic and placebo group showed features of SSI at the time of
suture removal on 7th post operative day.
Table 8: Infection distribution in two groups of patients at 2 week
Antibiotic Placebo
Total
(n=114)
(n=57) (n=57)
At 2 week
 No 55(96.5%) 55(96.5%) 110(96.5%)
1.000
 Yes 2(3.5%) 2(3.5%) 4(3.5%)

At 2 week
100 No
90 Yes
80
70
Percentage
60
50
40
30
20
10
0
When patients were reexamined during follow up after 2 weeks after surgery, 2(3.5%)
patients from each antibiotic and placebo group showed features of SSI.
Table 9: Infection distribution in two groups of patients at 4 week
Antibiotic Placebo
Total
(n=114)
(n=57) (n=57)
At 4 weeks
 No 56(98.2%) 55(96.5%) 111(97.4%)
1.000
 Yes 1(1.8%) 2(3.5%) 3(2.6%)

At 4 week
100 No
90 Yes
80
70
Percentage
60
50
40
30
20
10
0
During follow up of the patients at 4 week after surgery, 3(2.6%) patients had SSI out of
which 1(1.8%) patient was from antibiotic group while 2(3.5%) patients were from placebo
group. The differnce between two groups is not statistically significant(p=1.000).
Table 10: Other Complications distribution in two groups of patients studied
Antibiotic Placebo
Total
Other Complications Group group
(n=114)
(n=57) (n=57)
No 51(89.5%) 51(89.5%) 102(89.5%)
Yes 6(10.5%) 6(10.5%) 12(10.5%)
 Urinary
3(5.3%) 2(3.5%) 5(4.4%)
retention
 Seroma 2(3.5%) 2(3.5%) 4(3.5%)
 Hydrocele 1(1.8%) 2(3.5%) 3(2.6%)

Other Complications
100 No
Yes
80
Percentage
60
40
20
0
6 Antibiotic
Group(n=57)
5
Percentage
4
3
2
1
0
Urinary Seroma Hydrocele
retention Other Complications
Urinary retention 5 (4.4%), seroma formation 4(3.5%) and hydrocele 3(2.6%) were the other
complications which patients suffered from during postoperative days.
Table 11: Southampton grade distribution in two groups of patients studied
Southampton Antibiotic Placebo

Total
grade Group group
0 53(93%) 52(91.2%) 105(92.1%)
1a 0(0%) 0(0%) 0(0%)
1b 0(0%) 0(0%) 0(0%)
1c 0(0%) 0(0%) 0(0%)
2a 0(0%) 0(0%) 0(0%)
2b 0(0%) 1(1.8%) 1(0.9%)
2c 0(0%) 1(1.8%) 1(0.9%)
2d 1(1.8%) 0(0%) 1(0.9%)
3a 2(3.5%) 1(1.8%) 3(2.6%)
3b 1(1.8%) 2(3.5%) 3(2.6%)
3c 0(0%) 0(0%) 0(0%)
3d 0(0%) 0(0%) 0(0%)
4a 0(0%) 0(0%) 0(0%)
4b 0(0%) 0(0%) 0(0%)
5 0(0%) 0(0%) 0(0%)
Total 57(100%) 57(100%) 114(100%)
100
90 Antibiotic Group
80 Placebo group
70
Percentage
60
50
40
30
20
10
0
0 1a 1b 1c 2a 2b 2c 2d 3a 3b 3c 3d 4a 4b 5
Southampton grade
Table 12: Operative Time Minutes
Operative
Antibiotic Placebo
Time Total
Group group
Minutes
<45 2(3.5%) 6(10.5%) 8(7%)
45-55 44(77.2%) 43(75.4%) 87(76.3%)
>55 11(19.3%) 8(14%) 19(16.7%)
Total 57(100%) 57(100%) 114(100%)
Mean ±SD 51.28±4.19 50.81±4.39 51.04±4.26

Statistical test: Fisher Exact test
80 Antibiotic Group
70 Placebo group
60
Percentage
50
40
30
20
10
0
<45 45-55 >55
Operative Time Minutes
Mean operative time for whole study population was 51.04±4.26 minutes , whereas that of
antibiotic group and placebo group was 51.28±4.19 minutes and 50.81±4.39 minutes
respectively and the difference was not statistically significant (P=0.285).
Table 9: Type of SSI
Antibiotic Placebo
Type of SSI Total
Group group
Nil 53(93%) 52(91.2%) 105(92.1%)
1 4(7%) 5(8.8%) 9(7.9%)
2 0(0%) 0(0%) 0(0%)
Total 57(100%) 57(100%) 114(100%)
1= Superficial SSI
2= Deep SSI

Statistical test: Chi-Square test
100 Antibiotic Group

Placebo group
80
Percentage
60
40
20
0
Nil 1 2
Type of SSI
All SSI occurred in antibiotic as well as placebo group in this study were found to be
superficial SSI, no deep SSI was found in either of the group.
Table 10: Wound Culture
Wound Antibiotic Placebo

Total
Culture Group group
Nil 53(93%) 52(91.2%) 105(92.1%)
0 1(1.8%) 1(1.8%) 2(1.8%)
1 2(3.5%) 4(7%) 6(5.3%)
2 1(1.8%) 0(0%) 1(0.9%)
Total 57(100%) 57(100%) 114(100%)
0= no growth
1= staphylococcus aureus
2= more than one organism
Statistical test: Chi-Square test
100 Antibiotic Group

Placebo group
80
Percentage
60
40
20
0
Nil 0 1 2
Wound Culture
In our study, out of 9(7.9%) patients who developed SSI, 6(5.3%) patients had culture
positive for staphylococcus aureus [2(3.5%) from antibiotic group and 4(7%) from placebo
group] and 1(0.9%) patient from antibiotic group had culture positive for more than one
organism while 2(1.8%) patients [one from each antibiotic and placebo group] showed no
growth.
Discussion
Wound infection is one of the most commonly occurring surgical complications. Infection of
a wound may result from a number of factors both intrinsic and extrinsic to patient. Although
many of intrinsic factors can not be modified, the external ones can certainly be influenced.
In particular these are related to aseptic conditions, surgical technique and peri-operative
care. However even under the most scrupulous aseptic conditions and with a careful
technique, post-operative wound infection still present a very serious problem.
The use of antibiotic prophylaxis to avoid infectious complications of surgery is very
common in surgical practice. However, indiscriminate use of antibiotics can lead to problem
including an increase in cost and the emergence of resistant micro-organisms. The benefits of
antibiotic prophylaxis either in clean contaminated, contaminated and dirty surgery are
universally accepted. In clean surgery antibiotic prophylaxis is generally accepted when
placement of prosthetic materials or the presence of infection poses a significant risk to
patient. Nonetheless, controversy remains about the use of antibiotics in some types of clean
surgery.
Surgery for inguinal hernia is one of the most common techniques performed in general
surgery making up approximately a third of total interventions [3]. This type of surgery is
considered clean and it has been estimated that rate of post operative infection should not be
greater than 2% [4, 5]. Currently, the use of antibiotics prophylaxis is recommended for
elective open mesh inguinal hernia repair [4, 5]. However this treatment is not universally
accepted. For hernia repair not involving prosthetic material, the antibiotics prophylaxis is not
recommended in absence of risk factors but controversy arises when wound infection rates
exceed the expected figures [6, 7]. Contradictory results from clinical trials and the
investigating effectiveness of antibiotics prophylaxis have complicated this situation [8].
The overall SSI incidence was found to be 7.9% in our study population. This incidence is
slightly higher than the other studies. But a few other studies done by authors from South
India like Vinoth et al and Shankar et al show an incidence of 8.33% and 8.7% respectively.
There is no reliable data regarding the wound infection rates in the hospitals in the
developing world. The present study may play a role in enlightening us the reality about SSI
in developing countries. The incidence of surgical site infection following mesh repair of
inguinal hernia has been ranging from 0% to 9%.9 .Such a wide range on SSI rates is due to
the fact that studies differed in various aspects like difference in study design (retrospective,
non-randomized versus prospective, randomized), surveillance methods (surgical team versus
independent observer), definition of wound infection (no definition versus CDC definitions),
duration of follow-up, type of operation (mesh repair versus non-mesh repair).10
9. Law DJ, Mishriki SF, Jeffery PJ. The importance of surveillance after discharge from hospital in the
diagnosis of postoperative wound infection. Ann R Coll Surg Engl. 1990;72(3):207-9.
10. Terzi C. Antimicrobial prophylaxis in clean surgery with special focus on inguinal hernia repair with
mesh. J Hosp Infect. 2006;62(4):427-36.
Age
In our study, the mean age of the patients in antibiotic group was 42.67±11.67 years and the
mean age of patients in placebo group was 45.37±10.6 years. Whereas mean age of the whole
study population was 44.02±11.20 years. This is comparable with randomized controlled
study Razak et al in which mean age of patients in antibiotic group was 42.44±15.61 years and
that of patients in placebo group was 45.56±15.43 years while overall population had mean age
of 44.88±15.99 years. Mean age of the patients in a study done by Shankar et al was 45 years.
Sex
Out of 116 patients in our study all patients were male patients and no patient was female.
This is comparable with the studies done by Thakur et al, Sethi et al, and Vinoth et al which
also had no female patient in their study.
However in the study done by Kochhar et al out of total study population 203 were males
(95.7%) and rest 9 patients were females (4.3%). And in the study done by Ergul at al 16
(8%) patients were females out of 200 patients. The sex incidence in our study does not
correlate with the above mentioned studies. This may be due to the smaller number of
patients included in our study as well as the ignorance and reluctance of women in our
demographic area to seek medical attention.
Type of inguinal hernia

In our study, 31(27.2%) patients had direct hernia while 83(72.8%) patients had indirect
hernia. Difference in their distribution in antibiotic and placebo group was not statistically
significant. The incidence of type of hernia in our study is consistent with the analysis of
Saskia–Javi et al and KC B et al .in the study done by Saskia-Javi et al 47(87.03%) patients
were having indirect hernia while 7(12.87%) patients had direct hernia. KC B et al in their
study found 49 patients (82%) with indirect hernia and 11 patients (18%) with direct hernia
out of 60 patients. In the studies done by Sethi et al and Vinoth et al also majority of the
patients had an indirect hernia.
Side of hernia
In our study, in the antibiotic group 24(42.1%) patients had left sided hernia and 33(57.9%)
patients had right sided hernia. , while in the placebo group 27(47.4%) patients had left sided
hernia and 30(52.6%) patients had right sided hernia. Out of total population, 51(44.7%)
patients had left sided hernia and 63(55.3%) had right sided hernia. When analyzed with
respect to the type of hernia, both groups have statistically insignificant difference (P=0.833)
This is comparable to the study done by Gowri Sankar et al in which, 16(32%)patients in the
antibiotic group had left sided hernia and 34(68%) patients had right sided hernia. , while in
the placebo group 21(42%)patients had left sided hernia and 29(58%) patients had right sided
hernia. In the study done by Ergul et al 37 (37%) patients had left sided hernia and 63(63%)
patients had right sided hernia in the antibiotic group, while 40(40%) patients had left sided
hernia and 60(60%)patients had right sided hernia in the placebo group.
Antibiotic used
In this study Broad spectrum antibiotic intravenous 1.2 g of amoxicillin and clavulanic acid
combination in 20 ml of sterile saline was used and given by anaesthetist at the time of
administration of anaesthesia for patients in antibiotic group.
Boonchan et al in their network meta-analysis of antibiotic prophylaxis for prevention of
surgical-site infection after groin hernia surgery to compare the efficacy of different antibiotic
classes for prevention of surgical-site infection (SSI) after hernia repair concluded that 𝛃-
Lactam/𝛃-lactamase inhibitors followed by first-generation cephalosporins ranked as the
most effective SSI prophylaxis for adult patients undergoing groin hernia repair
In a cross-sectional survey of consultant-level general surgeons in London and the south-east
of England on their practices and beliefs regarding antibiotic prophylaxis in adult elective
inguinal hernia repair Aiken et al found a dose of 1.2 g of co-amoxiclav was the most popular
antibiotic choice for both hospital guidelines and surgeon’s usage.
Similar antibiotic was used as prophylaxis in the studies done by Ullah et al, Amit et al,
Othman et al, Jain et al, Tzovaras et al, and Oteiza et al.
Duration of surgery
Mean opertaive time for whole study population in this study was 51.04±4.26 minutes,
whereas that of antibiotic group and placebo group was 51.28±4.19 minutes and 50.81±4.39
minutes respectively and the difference was not statistically significant (P=0.285). This is
comparable with the studies done by Sethi et al, Razak et al, Shankar et al, and KC B et
al, Perez et al where average duration of surgery was 49 minutes, 53minutes, 53 minutes,
51.3 minute and 53 minutes respectively. It is lower than the study done by Yerdel et al who
reported mean duration of 63 minutes but it is higher than the study of Aufenacker et al who
showed mean duration of 40 minutes.
Organism
In our study, out of 9(7.9%) patients who developed SSI, 6(5.3%) patients had culture
positive for staphylococcus aureus [2(3.5%) from antibiotic group and 4(7%) from placebo
group] and 1(0.9%) patient from antibiotic group had culture positive for more than one
organism while 2(1.8%) patients [one from each antibiotic and placebo group] showed no
growth. Findings of our study are in conformity with the other Indian studies like Shankar et
al Sethi et al Kochhar et al and Amit et al according to which staphylococcus aureus is the
most common pathogen for SSI after open mesh repair of inguinal hernia.
Aufenacker et al, Perez et al, Othman et al, Wang et al, and Razak et al also showed
staphylococcus aureus as the most common organism found in wound culture.
Wound assessment
Southampton wound assessment scale was used to assess post-operative wounds which
enable to grade the wound according to specific criteria and therefore provide a more
objective assessment of the wound. Similar assessment scale was used in studies done by
Sethi et al and Gowri sankar et al.
Our incidence compared with other studies……

The incidence of surgical site infection following mesh repair of inguinal hernia has been
ranging from 0% to 9%. In our study, the overall infection rate is 9(7.9%) in patients
undergoing elective mesh repair of primary inguinal hernias. The incidence of SSI is 5(8.8%)
in control group and 4(7.1%) in the antibiotic group. Even though the incidence of wound
infection is higher in placebo group, it is not statistically significant (p=0.728). In our study
the overall incidence of SSI was near higher range of that reported in literature, which may be
due to small sample size and type 1 error.
Studies FAVOURING use of AB

The incidence of SSI was 9% in control group and 0.7 %in the antibiotic group in the study
done by Yerdel et al which showed a significant difference in SSI between the antibiotic and
control group. A study done by Usang et al reported SSI rate of 4.8% and 0% in the control
group and antibiotic group respectively and had similar results. Celdran et al reported
significant difference in SSI rates of placebo group (8%) and antibiotic group (0%).
Sanabria et al. (2007) in their meta-analysis on the prophylactic use of antibiotic in mesh
hernia repair assessed six randomized controlled trials using the Cochrane inclusion criteria
and concluded that antibiotic prophylaxis decreased the rate of surgical site infection almost
by 50%.
Jhang et al in their a meta-analysis of RCTs studying the use of antibiotic prophylaxis to
prevent postoperative complications in patients undergoing tension-free hernioplasty
including 6 RCTs conducted around the world concluded that antibiotic prophylaxis use in
patients undergoing tension-free hernioplasty decreases the rate of incision infection by 55%.
In a literature search done by Yuan et al in databases of MEDLINE, EMBASE, and
Cochrane Central Register of Controlled Trials, where 9 randomized controlled trials were
included, they concluded that antibiotics did reduce the rate of SSI after mesh inguinal hernia
repair.
Studies AGAINST use of AB

Aufenacker et al showed that the incidence of SSI was 1.8% in the control group and 1.6 %
in the antibiotic group. The author concluded that prophylactic antibiotics did not prevent SSI
in open mesh repair of inguinal hernias. The SSI rates reported by Perez et al were 3.3% and
1.7% in the control and antibiotic group respectively and the author did not find any benefit
with antibiotic prophylaxis. A similar conclusion was drawn by Tzovaras et al who found the
incidence of SSI in control group and antibiotic group as 4.6% and 2.5% respectively.
Jain et al reported infection rate of 1.7% in antibiotic group, in the placebo group infection
rate was also 1.7%. Author concluded that antibiotic prophylaxis is not required. Shankar et
al reported 7% infection in antibiotic group and 10.5 % in control group. They also did not
support the use of antibiotic prophylaxis. Ergul et al 5% infection in antibiotic group and 7%
infection in placebo group which was not statistically significant. Othman et al and Amit et
al also concluded that antibiotic prophylaxis have no role in hernia repair. Amit et al had
infection rate of 1% and 3% in antibiotic and placebo group respectively, while Othman et al
had 2% infection rate in both the groups.
In a Cochrane review conducted by Sanchez- Manuel and Seco-Gil 2006, including 8 RCTs
based on the results of 2,907 patients concluded as: “In conclusion, the results of this
metaanalysis show that antibiotic prophylaxis may be useful to prevent wound infection in
open elective hernia repair. However, the data are sufficiently strong neither to recommend
its universal administration nor to recommend against its use when high rates of wound
infections are observed.”
Preoperative hospital
Shankar et al found a positive correlation between duration of preoperative hospital stay and
the development of postoperative SSI. The mean preoperative hospital stay was 5.31 days in
patients with SSI in comparison to 4.06 day in patients without SSI. Difference was
statistically significant (p=0.035). No other study has shown such a difference in hospital
stay.
Razak et al found a positive correlation between the duration of pre-operative hospital stay
and the development of post-operative SSI. The mean pre-operative hospital stay was
5.31±3.16 days in the patients with SSI in comparison to 4.06±3.03 days in patients without
SSI. The difference was statistically significant (p=0.035).
This correlation between preoperative hospital stay and postoperative SSI rate is not valid as
majority of our patients were admitted one day before surgery.
Time of diagnosis of SSI

No patient in our study developed SSI before discharge; all were diagnosed during follow up,
most often during their first scheduled visit after suture removal in the second postoperative
week. In the studies done by Perez et al, Celdran et al, Usang et al, Ergul et al, Sethi et al
all the infections were diagnosed after discharge. So our study is in concurrence with
literature. Yerdel at al found 5 of 13 of infections during hospital stay with in hospital rate of
30.7%. However the infection rate is very high in his study.
Superficial vs deep
Vast majority of SSI occurring after hernia repair are superficial SSI. All SSI occurred in our
study were superficial while no SSI was deep. All the SSI reported in the studies done by
Ergul et al, Jain et al, Celdran et al, Tzovaras et al, Vinoth et al, Gowri Sankar et al
were superficial infections. So our study is in concurrence with literature.
Mesh removal
The incidence of mesh infection reported in literature varies from 0.35% to 1%. None patient
had mesh removal due to SSI in our study similar to the studies done by Gowri Sankar et al,
Tzovaras et al, Ergul et al and Amit et al. Aufenacker et al reported an incidence 0.3% for
deep SSI in their study within a follow up period of 3 months. No patients in their study
required mesh removal similar to our study. Perez et al reported deep SSI rate of 0.6% in
both group. 1 patient was detected to have deep infection and subsequent mesh removal was
required in both of them.
Yerdel et al reported 1 patient (0.7%) deep SSI in antibiotic group and 3(2.2%) patients in
placebo group. The difference was not statistically significant (p=0.367). Three patients of
placebo group required mesh removal.
The incidence of deep SSI by Shankar et al was 0.6% with one patient in each group having
deep SSI. One patient required mesh removal in their study. Othman et al also noticed one
patient in each group with deep SSI giving deep SSI rate of 2%. No patient required mesh
removal.
Risk of recurrence
In case of SSI, especially, deep SSI the risk of risk of recurrence should also be evaluated.
However the results of Celdran et al suggested that occurrence of infection does not increase
rate of recurrence. Even when the removal of mesh has been necessary to resolve infection,
the fibrotic reaction around posterior wall of the inguinal canal may prevent the recurrence.
No recurrence was noticed in our study in infected patients however follow up time of our
patients was very small.
Lacunae in
The economic impact of SSI was not assessed in our study. However since all infections were
Superficial SSIs and were managed by wound dressing antibiotics only, we believe the cost
effectiveness of antibiotic prophylaxis in the absence of conclusive benefit is questionable.
In order to detect 50% difference between both groups and to have sufficient statistical power
a prospective randomised blinded study should include at least 800 patients in each treatment
arm. This involves performing multicentre studies or studies with longer recruitment periods.
This is the major limitation most studies face.
Potential drawback of this study is a smaller study population. Depending on the sample size
formula and base rate of SSI, to perform a RCT with enough power to detect a 50% decrease
SSI rates, it will be necessary to include 3000 patients. If we want to detect even smaller
percentage decrease in SSI larger study population is needed. Another drawback is we
followed up the patients only for four weeks but according to CDC criteria, if implant is used,
then any infection occurring up to 1 year will be considered as SSI.
Ergul ….Encouraging aspects of our trial were the absence of DSSI and that all SSSI
responded well to proper antibiotics with or without drainage.
The shortcomings of our study are the lack of data about the nutritional status, obesity, and
smoking status of patients, all of which are patient-related factors that may affect the risk of
development of wound infection [7].
In fact, the incidence of infection in specific hernia centres where only elective hernia repairs
are conducted is not higher than 1% [33]. Our results were worse than those of specific
centres. A strict prophylaxis and preoperative care protocol could not reduce our incidence of
infection. This is probably because of regional and institutional factors. In our setting,
inguinal hernia repairs are scheduled after major abdominal surgery and, when necessary,
even contaminated trauma cases are admitted between the elective cases. We therefore plan
to establish a specific hernia centre in our hospital in a separate place with separate entry.
Consequently, we were not able to demonstrate any significant benefit of antibiotic
prophylaxis in elective tension-free mesh repair of inguinal hernia. We believe the effective
way to reduce our incidence of infection in prosthetic inguinal hernia repair in our hospital
would be to improve infection-control procedures and, perhaps, establish a specific in-
hospital hernia-repair centre.
CONCLUSION
The present study is a comparative double blind study between antibiotic and placebo group
for SSI prevention in open hernia surgery. The study was conducted with an intention to
observe the effect of prophylactic antibiotic in prevention of SSI after Lichtenstein’s tension
free open mesh hernia repair. The patients were followed up in the postoperative period at
intervals of one week, two week and four week. Patients were assessed for presence of SSI
defined by CDC criteria.
In our study we found that SSI is not an uncommon complication following Lichtenstein’s
tension free open mesh hernioplasty. Rate of SSI was high both in the antibiotic and placebo
group compared to the incidence of SSI in open hernia mesh repair, reported worldwide
though they were comparable to the SSI rates found in the studies done in India. In our study
even though the rate of SSI was high in both antibiotic and placebo group the difference was
not statistically significant. This indicates that routine use of prophylactic antibiotics does not
decrease the incidence of SSI in Lichtenstein tension free open mesh hernioplasty.
There are few limitations to our study including a small sample size, lack of data about the
nutritional status, obesity, and smoking status of patients, all of which are patient-related
factors that may affect the risk of development of wound infection, relatively short duration
of the study, the requirement for a longer follow up period.
SUMMERY
In our study incidence of hernia was more common (28.9%) in the age group of 41-50 years.
All affected patients were men we did not come across any female patient.
Right side (55.3%) hernia was seen more common than left side (44.7%).
Incidence of Indirect hernia (72.8%) was far more common than direct hernia (27.2%)
Our study included 116 patients, out of which 56 were in antibiotic group while 56 were in
placebo group; their distribution was done by preoperative random allocation.
Mean operative time for whole study population was 51.04±4.26 minutes , whereas that of
antibiotic group and placebo group was 51.28±4.19 minutes and 50.81±4.39 minutes
respectively and the difference was not statistically significant (P=0.285).
Patients were discharged on next day of surgery and reexamined during follow up at the time
of suture removal, 2 weeks and 4weeks after surgery.
Out of 116 patients 9(7.9) patients had SSI after open mesh repair .The incidence of SSI was
4(7.1%) patients in antibiotic group and 5(8.8%) patients in placebo group. There was no
statistically significant difference in antibiotic and placebo group (p=0.728). SSI was defined
as per CDC criteria.
All SSI occurred in antibiotic as well as placebo group in this study were found to be
superficial SSI, no deep SSI was found in either of the group.
All infections were diagnosed during follow up of the patient after discharge from hospital.
Most of the infections (4 out of 9) were diagnosed during second week of follow up.
Staphylococcus aureus (6 out of 9) was the most common organism found in wound culture
of patients with SSI in this study.
Urinary retention 5(4.4%), seroma formation 4(3.5%) and hydrocele 3(2.6%) were the other
complications which patients suffered from during postoperative days.
Southampton assessment scale was used to grade the wounds, where we found that three
patients had wound of grade 3a and 3b each while grade 2b, 2c and 2d wounds (one of each
grade) were seen in other three patients.
RECOMMENDATIONS
On the basis of our study, we make following recommendations:
 Antibiotic prophylaxis should not be used routinely in cases of Lichtenstein tension

free open mesh hernioplasty
 To further validate study findings, we recommend a multi-centric study with larger
sample size.
 Based on SSI rate each institute should be classified under low risk vs high risk
environment.
 We recommend future comparative studies considering associated risk factors for SSI
development and classifying patients preoperatively in high risk and low risk.
 We also recommend studied comparing economic burden of use of antibiotic
prophylaxis v treatment of SSI after Lichtenstein tension free open mesh hernioplasty.
 We recommend to establish a specific in-hospital hernia-repair centre with improved
infection-control procedures to reduce rate of SSI.
REFERENCES
Illustrations
Figure - showing spinal anaesthesia

ANNEXURE II: PATIENT INFORMATION SHEET
Introduction
I, Dr. SOMNATH KARAD, DNB trainee, in the Department of General Surgery, Ispat
General Hospital, Rourkela, am working on my DNB Thesis titled “ROLE OF ANTIBIOTIC
PROPHYLAXIS IN OPEN MESH REPAIR OF PRIMARY INGUINAL HERNIA –A
RANDOMISED PROSPECTIVE STUDY”
I am going to give you information and invite you to be part of this study. Before you
decide, you can talk to anyone you feel comfortable with about the study. Your decision to
participate or not will not have any effect on your health anyway. There may be some words
you may not understand. Please ask me to stop midway through the information and I will
take time to explain. If you have questions later, you can ask them and get yourself clarified.
Purpose of the study:- Purpose of the study is to reach at a conclusion whether antibiotic
prophylaxis is routinely used in all open mesh repair of primary inguinal hernia .
Participation selection:- patients diagnosed with primary inguinal hernia and admitted for
elective laparoscopic cholecystectomy in the Department of General Surgery, Ispat General
Hospital, Rourkela, during the period of August 2016 to February 2018 will be included in
this study.
Voluntary participation:- Your participation in this study is entirely voluntary. It is your

choice whether to participate or not. Whether you participate or not it will not affect your
treatment in anyway. You have every right to withdraw at any step in the study process.
Procedure and protocols:- Various questions will be asked regarding your personal data,
complaints, history of exposure to risk factors. Followed that general and clinical
examination will be done and appropriate investigations will be advised.
Benefits:- You are not expected to get any benefit from being on this study apart from
treatment benefit.
Risks:- There are no risks or any inconvenience of being in this study.
Reimbursement:- You will not be given any money or gifts to take part in this study.
Confidentiality:- The information that we collect from this study will be kept confidential.
Information about you that will be collected during the study will be put away and no one but
the researchers will be able to see it.
Showing the results:- The knowledge that we get from doing the study will be shared with
you. Confidential information will not be shared. We will publish the results in order that
other interested people may learn from our study.
Right to refuse or withdrawal:- You do not have to take part in this study if you wish to do
so and can be withdrawn from the same any time you wish to do. It is your choice and all of
your rights will still be respected.
Who to contact:- This proposal has been reviewed and approved by the scientific and
research committee of Ispat General Hospital, Rourkela, which is a committee whose task is
to make sure that research participants are protected from harm. You can ask me any more
questions about any part of the research study, if you wish to.
ANNEXURE III: INFORMED CONSENT FORM
I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it and any questions that I have asked have been answered to my
satisfaction. I consent to participate as a participant in this study.
Name of the participant/ guardian (in case of minor):
Signature or thumb impression of the participant/ guardian (in case of minor):
(If the participant is illiterate, a literate witness person selected by the participant must sign
the form and the participants who are illiterate should include their thumb print as well)
I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had opportunity to ask questions. I confirm that the individual has given
consent freely.
Name of the witness:
Signature of the witness:
Date:
Statement by the researcher/ person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of
my ability in their own language. I have made sure that the participant understands the
procedure and study to be done.
I confirm that the participant was given an opportunity to ask questions about the study, and
all the questions asked by the participant have been answered correctly to the best of my
ability. I confirm that the individual has not been coerced into giving the consent, and the
consent has been given freely and voluntarily. A copy of the consent has been provided to the
patient.
Name of the Researcher/ person taking the consent: Dr. SOMNATH KARAD
Signature of the Researcher/ person taking the consent:
Date:
Name: Age: Sex:
Occupation: Marital status:
Address:
Socio-economic status Reg. No.:
Date of admission:
Date of surgery:
Date of discharge:
PREOPERATIVE EVALUATION:
Chief complaints:
History of present illness:
Past history:
Personal history:
Family history:
Gynaecological/ obstetric history:
PHYSICAL EXAMINATION
Sensorium Facies: Decubitus:
Built: Nutrition: BMI:
Pallor: Cyanosis: Icterus:
Clubbing: Oedema: Lymphadenopathy:
Pulse: BP: Temperature:
Respiration: SpO2
SYSTEMIC EXAMINATION
 1.Abdominal examination:
 2.Respiratory system:
 3.CVS;
 4.CNS:
 5.Genitourinary:
CLINICAL FINDINGS:
LAB INVESTIGATIONS:
CBC- Serum electrolyte-
FBS/RBS- BT/CT-
RFT- PT/INR-
HIV - HbsAg - Anti HCV-
CHEST X-RAY:
ECG:
OPERATIVE TIME:
OPERATIVE FINDINGS:
POST OPERATIVE COMPLICATIONS:
 Time of occurrence
 Signs of infection which will be looked for SSI diagnosis–
Erythema,
Tenderness/Pain,
Discharge
Day of Superficial Deep Southampton Wound Other

examination SSI SSI grade culture complication
At the time of
discharge
At the time of
suture removal
(7 day)
After 2 week
After 4 week

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“ROLE OF ANTIBIOTIC PROPHYLAXIS IN OPEN MESH

REPAIR OF PRIMARY INGUINAL HERNIA – A

In partial fulfillment of the requirement for the award of degree of

D.N.B. (GENERAL SURGERY)

Under the guidance of

JOINT DIRECTOR & HEAD OF THE DEPARTMENT

DEPARTMENT OF GENERAL SURGERY

Dr. BINAYAK RATH, MS (GENERAL SURGERY)

SENIOR CONSULTANT, DEPARTMENT OF GENERAL SURGERY

Dr. SOMNATH KARAD

JANUARY 2016 SESSION

ISPAT GENERAL HOSPITAL, ROURKELA (ODISHA)

This is to certify that the thesis entitled “ROLE OF ANTIBIOTIC

PROPHYLAXIS IN OPEN MESH REPAIR OF PRIMARY

INGUINAL HERNIA – A RANDOMISED PROSPECTIVE STUDY”

is a bonafide and genuine research work carried out by Dr. SOMNATH

KARAD for DNB examination in General Surgery to be held in

ISPAT GENERAL HOSPITAL

This is to certify that the thesis entitled “ROLE OF ANTIBIOTIC

PROPHYLAXIS IN OPEN MESH REPAIR OF PRIMARY

INGUINAL HERNIA –A RANDOMISED PROSPECTIVE STUDY”

is a bonafide and genuine research work carried out by Dr. SOMNATH

KARAD for DNB examination in General Surgery to be held in

Ispat General Hospital

This is to certify that the thesis entitled “ROLE OF ANTIBIOTIC

PROPHYLAXIS IN OPEN MESH REPAIR OF PRIMARY

INGUINAL HERNIA –A RANDOMISED PROSPECTIVE STUDY”

is a bonafide and genuine research work carried out by Dr. SOMNATH

KARAD for DNB examination in General Surgery to be held in

ISPAT GENERAL HOSPITAL

I hereby declare that, National board of Examinations, New-Delhi, shall

Dr. Somnath Karad

I hereby declare that this Thesis “ROLE OF ANTIBIOTIC

Dr. Somnath Karad

I express my deepest sense of gratitude and indebtness to Dr. B N Sarkar, Dr. M K

Dr. Somnath Karad

NOTES = Natural Orifice Transluminal Endoscopic Surgery

OCG = Oral Cholecystography

MRI = Magnetic Resonance Imaging

MRCP = Magnetic Resonance Cholangiopancreatography

ESWL = Extracorporeal Shock Wave Lithotripsy

MTBE = Methyl Tetra Butyl Ether

US FDA = Food and Drug administration in USA

TLC = Total leucocyte count

PPV = Positive predictive value

NPV = Negative predictive value

ERCP = Endoscopic retrograde cholangiopancreatography

BMI = Body mass index

COPD = Chronic obstructive pulmonary disease

LFT = Liver function tests

Serial No. Contents Page No.

2. Aims & Objectives 3

4. Material & Methods

5. Observations & Results

II. Patient information sheet

III. Informed consent form

IV. Study Proforma

Fig No. Figure Page No.

1. Anatomy of the extrahepatic biliary tree 5

2. Diagrammatical representation of hepatocystic triangle and Calot’s 6

4. A brief graphic description of the OT set used in our study 30

5. Age distribution of the study population 34

6. Sex distribution of the study population 35