Five-year results of a

randomised controlled multi-

centre study comparing
heavy-weight knitted versus Pembimbing :
low-weight, non-woven dr. Bambang Sugeng, Sp. B

polypropylene implants in
Lichtenstein hernioplasty Disusun oleh :
Hanny Fuzi Lestari

L/O/G/O

KEPANITERAAN KLINIK ILMU BEDAH

FAKULTAS KEDOKTERAN UNISSULA SEMARANG
RS ISLAM SULTAN AGUNG
Juni 2016
JOURNAL IDENTITY
• Five-year results of a randomised controlled
multi-centre studycomparing heavy-weight
Title knitted versus low-weight, non-
wovenpolypropylene implants in
Lichtenstein hernioplasty

• M. Jmietajski ·
• K. Bury ·I. A. Jmietajska ·
Author • R. Owczuk
• T. Paradowski ·
• The Polish Hernia Study Group

Published at: • 25 March 2011

• Hernia The World Journal of Hernia and

Published by: Abdominal Wall Surgery
INTRODUCTION
HERNIA  Lichtenstein MESH
HERNIOPLASTY technique IMPLANTATION

Material- POST-OP Inflammatory

reduced PROBLEM : reaction and scar
meshes The recurrence tissue formation
and pain rate caused by mesh

NOT
NON WOVEN (NW) Documented as a reason
POLYPROPYLENE for decreased rate of
pain
• The WN mesh  a low-weightmesh, not knitted
or woven, that was designed as a highly porous
polypropylene sheet

LOW WEIGHT NON WOVEN HEAVY WEIGHT KNITTED

POLYPROPILANE (WN ) POLYPROPILANE (HW)
HYPOTHESIS
• The WN mesh would cause less pain at
short- and long-term observations
 METHODS

Study • prospective randomised

controlled multi-centre
Design blinded study

Place • in four hospitals in Poland.

 SAMPLE
• Patients diagnosed with primary inguinal
hernia who were aged between 20 and 75
years
INCLUSION

• Patients with a history of inguinal hernia repaired with

: a synthetic mesh, chronic immunosuppressive /
corticosteroid therapy / Radio- or chemotherapy
currently or in the past 3 months,
• chronic renal failure (on dialysis),
• hepatic failure
EXCLUSION • active bacterial endocarditis, proven mental illness,
• thrombocytopenia (platelets <100 X 10 9/l)
• pregnant
 RESULTS
PATIENT BASELINE DATA
PERIOPERATIVE AND POSTOPERATIVE COMPLICATION
FREQUENCY OF PAIN
VAS score
RESUME OF RESULT
• TABLE 1 : After randomisation, statistical differences was noted
between the groups according to hernia size (medium indirect
hernias were often presented in the WN group, smaller indirect in
the HW PP group).
• TABLE 2 : The median operative time was 40 min (15–125 min) for
the WN group and 35 min (20–95 min) for the HW PP group (P =
0.43). No serious perioperative or postoperative complications were
noted in either group, and there were no statistically significant
differences between the groups, except that wound redness (1% vs
8.1%; P = 0.013)
The incidence of recurrence was slightly higher in the HW PP group
(3%) than in the WN group (1%) at 5 years, but no statistical
difference was found (P = 0.61). All recurrences were in male
patients and occurred within the first 2 years of follow-up. In all
cases, the recurrence was found above the pubic bone at the mesh
margin
• TABLE 3 : not significant due to the small number of
patients suffering from pain in both groups, but
Postoperative measurements revealed a signifficantly
higher frequency of pain in the HW PP group
• VAS scale : The intensity of pain measured in VAS (data
were counted for the whole group, not only for the
patients with pain) was also lower in the WN
group,although a statistical difference was found only 7
days postoperatively(P = 0.0012)
 Study limitations
• In this study, not observe any recurrences
in the WN group up to 1 year, and very low
recurrence rates after 5 years
 CONCLUSION
• Use of a lightweight non-woven Polypropylene
implant is a valuable alternative to the use of
knitted or woven meshes in the Lichtenstein
method.
• Postoperative pain and recurrence were
reduced at short term follow-up, but no statistical
difference in recurrence rate was observed at 12
and 60 month follow-up in the patient population
tested.
DISCUSSION
• The extent of reaction to a foreign body, with the scar
tissue and inflammatory reaction it provokes, depends
on the amount and structure of the material implanted

• An absorbable component has been added to the

polypropylene fibres to decrease the weight of mesh
during the incorporation process, and the potential
advantage conferred by partially absorbable lightweight
meshes, such as Vypro, Vypro II and Ultrapro

• Early postoperative pain depended on the mesh used

• Low weight partially absorbable meshes  the tissue
reaction and fibroblastic ingrowth creates a scar that is
responsible for mesh shrinkage  Formation of an
elastic scar on megaporous meshes prevent pain and/or
a feeling of a foreign body in the groin

• the total amount of macrophages at the site of the mesh

was statistically higher in the non-woven mesh group
• recurrence has been shown in 3–5 years of follow-up
 Critical Appraisal for Therapy
Journal
• Title
Five-year results of a randomised controlled multi-centre
studycomparing heavy-weight knitted versus low-weight, non-
wovenpolypropylene implants in Lichtenstein hernioplasty
Positive:
– Consist of less than 12 words
– Consist of variables studied
– Bold
– No abbreviation
• authors
M. Jmietajski · K. Bury · I. A. Jmietajska · R. Owczuk T. Paradowski
· The Polish Hernia Study Group
• Publicator:
Hernia The World Journal of Hernia and Abdominal Wall Surgery
Abstract

• Positive Negative :
Consists of : Background, •More than 200 words (
Methods, Result, the 218 )
objective, conclusion and
keyword
 Methods
• Clear sample and inclusion criteria
Positive •
•
Clear intervention among groups
Analytical studies were clearly mentioned
• Outcome were clearly measured

Negative • -
 Result
• Accompanied by tables presented in accordance with
the format of International Journal Writting (without
Positive inner vertical and horizontal lines) and serial number,
table title and description of the content
• Statistical value was written

Negative • -
 Discussion
• There are comparisons test of previous
studies and the theory
• There mentioned drawbacks and
advantages of research results that have
Positive been achieved
• There is an emphasis if the results of the
research will be applied
• Any suggestions for future research

negative •-
 Internal Validity
• Patients – Lichtenstein inguinal hernioplasty patients
• Intervention –non-woven polypropylene implants
• Comparison – heavy-weight polypropylene implants
• Outcome(s) – incidence recurrence rate, and
postoperative pain.
 Validitas Uji
Con’t internal validity
Apakah Bukti ini valid?
1 Apakah digunakan intention to treat analysis: yakni semua ya
pasien harus dianalisis sesuai dengan keadaan/ alokasi
awalnya tanpa melihat apakan pasien tersebut akan
menyelesaikan penelitian atau tidak.
2 Apakah dilakukan randomisasi dan apakah daftar ya
randomnya disegel?Apakah RCT?
3 Apakah klompok yang dibandingkan sebanding di awal ya
percobaan?
4 Apakah blind?singel atau double blind? ya
5 Apakah kelompok diperlakukan sama kecuali kelompok ya
yang akan diterapi untuk diteliti?
6 Apakah semua pasien yang masuk dalam penelitian ya
diperhitungkan dalam simpulan akhir dan semua
dianalisis sesuai dengan keadaan awalnya?
Apakah Bukti ini Penting?
1 Seberapa besarkah pengaruh terapi tersebut (Lihat NNT) tidak
2 Seberapa besar persisi estimasi dari pengaruh terapi Tidak
tersebut?(Lihat CI)
• RRR = - 0,021(95% CI: - 0,063
to 0,019)
Jika WN digunakan sebagai
terapi maka dapat mengurangi
kekambuhan sebesar 2,1%
– ARR = - 0,02 (95% : - 0,0268 to
0,076)
Bila WN digunakan sebagai terapi
, maka selisih jumlah insiden
kekambuhan anatar WN dan HW
PP sebesar 2 %

• NNT = -50 (-13 to 35)

Setiap kita melakukan terapi

WN terhadap 50 pasien, maka
akan mencegah 1 pasien yang
kambuh

IK (-13 to 35) mencakup angka 1,

maka nilai NNT menjadi tidak
bermakna
 External Validity/Applicability
Apakah Bukti ini valid?
1 Apakah pasien kita terdapat perbedaan dengan subjek tidak
pada penelitian.
2 Apakah terapi tersebut mungkin untuk diterapkan pada ya
pasien kita (dengan setting kita)
3 Apakah pasien kita mempunyai potensi yang ya
menguntungkan atau merugikan jika terapi tersebut
diterapkan?
4 Apakah nilai dan pengharapan pasien kita bila hasil penelitian ya
tersebut kita tawarkan untuk mengobati
5 Apakah terapi baru tersebut tersedia? ya
 KESIMPULAN
1

• the therapy study is VALID

• the therapy study is IMPORTANT

• the therapy study is APPLICABLE

Thank You