A RANDOMIZED CONTROL TRIAL OF FLAP TACKING

VERSUS NON FLAP TACKING IN INCISIONAL HERNIA AND

ITS OUTCOME ON SEROMA FORMATION

DR.V. Bharathi
MS General Surgery
Stanley Medical College and Hospital
INTRODUCTION

•Incisional hernia (IH) is the most frequent long-term

complication after midline laparotomy with incidences
between 11% and 25%.

•A frequently experienced problem with the retromuscular

(RM) technique, without component separation (CS), was the
inability to cover the mesh with fascia, leaving the mesh
exposed to subcutaneous tissue with increased risk for
seroma formation and wound/mesh infection .
INTRODUCTION
•IN FLAP TACKING after mesh placement, closure of rectus
to subcutaneous tissue is done, its provide better outcome
in

•Reducing seroma collection due dead space obliteration.

• Early drainage tube removal.

•Early wound healing and decreased surgical site infection.

AIM
• To assess the superiority of flap tacking technique over the
non flap tacking in incisional hernia on its outcome of
seroma collection and surgical site infection, early DT
removal and recovery.
•To access the correlation between the post operative
findings with the surgical techniques.
METHODOLOGY
PLACE OF STUDY: Department of General Surgery-
Govt Stanley Medical College, Chennai

DURATION:12months(APRIL 2021 TO APRIL 2022)

STUDY DESIGN:CASE CONTROL STUDY

STUDY POPULATION: incisional hernia patients posted

for anatomical on lay mesh repair
 CRITERIA

Inclusion criteria Exclusion criteria

• Age group:25 -60 • Patients below 25 yrs of

YEARS age

• Patients admitted with • Patients not fit for

incisional hernia , anaesthesia.
anatomical onlay mesh
repair • Planned for anatomical
• Willing to participate other than onlay mesh
repair
• Sample size:
• Using open epi software, assuming the proportion of outcome
in the control and intervention arm as 60 % and 40 % , ratio of
participant in both arm as 1:1, the estimated sample size for the
study as follows, and 80 participants will be included in each
arm of the study.
METHOD OF DATA COLLECTION
•Written and informed consent study done in patients admitted in our unit for
anatomical onlay mesh repair for incisional hernia the study period from April 2021 –
April 2022.

• In anatomical onlay mesh repair, flap tracking is done by suturing rectus to

subcutaneous tissue using 3’0 vicryl after mesh placement. The patients will be evaluated
with following factors

Interventional arm: Those consented participants admitted on odd days of the month
will be included.
Control arm: Those consented participants admitted on even day of the month will be
included

•HISTORY - Age, sex, h/o previous hospitalisation ( abdominal surgeries)

•CLINICAL- BMI, abdominal scar, infraumbilical or supraumbilical scars

•IMAGING -usg showing defect size and content of sac

 PROFORMA
A RANDOMIZED CONTROL TRIAL OF FLAP TACKING VERSUS NON FLAP
TACKING IN INCISIONAL HERNIA AND ITS OUTCOME ON SEROMA
FORMATION

•NAME
•AGE/SEX
•Ht: wt:. BMI:
•DATE OF ADMISSION
•DATE OF SURGERY
•IP.NO
•COMPLAINTS
•COMORBIDITIES
•PREVIOUS SURGERY -
•TREATMENT HISTORY
•VITALS :PR= ,BP= , TEMP= ,RR=
•GENERAL EXAMINATION
•SYSTEMIC EXAMINATION
CVS
RS
PER ABDOMEN :
 GOVT.STANLEY MEDICAL COLLEGE, CHENNAI- 600 001
INFORMED CONSENT
A RANDOMIZED CONTROL TRIAL OF FLAP TACKING VERSUS NON FLAP TACKING IN
INCISIONAL HERNIA AND ITS OUTCOME ON SEROMA FORMATION
PLACE OF STUDY: GOVT. STANLEY MEDICAL COLLEGE, CHENNAI
NAME AND ADDRESS OF PATIENT:
•I, _____________________ have been informed about the details of the study in my
own language.
•I have completely understood the details of the study.
•I am aware of the possible risks and benefits, while taking part in the study.
•I understand that I can withdraw from the study at any point of time and even then, I
will continue to receive the medical treatment as usual.
•I understand that I will not get any payment for taking part in this study.
•I will not object if the results of this study are getting published in any medical journal,
provided my personal identity is not revealed.
•I know what I am supposed to do by taking part in this study and I assure that I would
extend my full co-operation for this study.
Name and Address of the Volunteer: Signature/Thumb impression of the Volunteer
Date:
Witnesses:
(Signature, Name & Address) Date:
Name and signature of investigator:
 GOVT.STANLEY MEDICAL COLLEGE, CHENNAI- 600 001
INFORMED CONSENT

A RANDOMIZED CONTROL TRIAL OF FLAP TACKING VERSUS NON FLAP TACKING IN INCISIONAL
HERNIA AND ITS OUTCOME ON SEROMA FORMATION

PLACE OF STUDY: GOVT. STANLEY MEDICAL COLLEGE, CHENNAI

NAME AND ADDRESS OF PATIENT:

•____________ஆகியஎனக்கு,எனதுசொந்தமொழியில்ஆய்வுவிவரங்கள்பற்றிதெரிவிக்கப்பட்டது.நான்ஆ
ய்வுவிவரங்கள்பற்றிமுற்றிலும்அறிந்துகொண்டேன்.

•ஆய்வில்பங்கெடுத்துள்ளநான்,சாத்தியமானஅபாயங்களையும்,பயன்களையும்நன்குஅறிந்திருக்கிறே
ன்

•நான்எந்தநேரத்திலும்இந்தஆய்விலிருந்துவெளிவரமுடியும்என்றும்அதன்பின்னர்,நான்வழக்கம்போல்
மருத்துவசிகிச்சைபெறலாம்என்றும்புரிந்துகொண்டேன்.

•நான்இந்தஆய்வில்பங்குகொள்வதால்எந்தபணமும்பெறமுடியாதுஎன்பதையும்அறிந்தேன்.

•இந்தஆய்வின்முடிவுஎந்தமருத்துவஇதழிலும்வெளியிடப்படலாம்என்றும்,எனினும்எனதுதனிப்பட்ட
அடையாளம்வெளியிடப்படாதுஎன்றும்நன்குஉணர்ந்தேன்.

•நல்லெண்ணத்துடன்மேற்கொள்ளப்படும்இந்தஆய்வில்பங்குகொள்வேன்என்றும்எனதுமுழுஒத்துழை
ப்பைநீட்டிப்பேன்என்றும்உறுதியளிக்கிறேன்.

•பெயர்மற்றும் முகவரி:
• கையொப்பம்/ பெருவிரல்ரேகை:
•நாள்:
•சாட்சிகள்: (கையொப்பம், பெயர்மற்றும்முகவரி)
•நாள்:
•பெயர்மற்றும்புலன்விசாரணையாளர்கையொப்பம்: