Five-year results of a

randomised controlled multicentre study comparing

heavy-weight knitted versus
low-weight, non-woven
polypropylene implants in
Lichtenstein hernioplasty

Pembimbing :
dr. Bambang Sugeng, Sp. B

Disusun oleh :
Desia Laila Dian S (012106117)

L/O/G/O

KEPANITERAAN KLINIK ILMU BEDAH

FAKULTAS KEDOKTERAN UNISSULA SEMARANG
RS ISLAM SULTAN AGUNG
NOVEMBER 2014

JOURNAL IDENTITY

INTRODUCTION

 The WN mesh a low-weightmesh, not knitted

or woven, that was designed as a highly porous
polypropylene sheet

LOW WEIGHT NON WOVEN

POLYPROPILANE (WN )

HEAVY WEIGHT KNITTED

POLYPROPILANE (HW)

HYPOTHESIS
The WN mesh would cause less pain at
short- and long-term observations

METHODS

SAMPLE

STATISTICAL ANALYSIS
Statistical calculations were performed using
Statistica 7.1 PL (Polish version) software
(StatSoft, Tulsa, OK).
Descriptive statistics (characterise patient
groups, mean (standard deviation) or median
values (range of values)
Normal data distribution in the interval scale.

 Group Normal distributions W ShapiroWilks test.

Data were compared using Students t test or the Mann
Whitney U test. Repeated measurements were analysed
using a twoway analysis of variance (ANOVA) test
signifcant differences with the post-hoc method (HSD
Tukeys test) when appropriate.
Categorical data were presented as percentages and 95%
confidence intervals and compared using a chisquare test,
with the Yates correction applied when necessary.
A signiWcance level of P < 0.05 was adopted.

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 (15125 min) for the
WN group and 35 min (2095 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 35 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
Consists of : Background,
Methods, Result, the
objective, conclusion and
keyword

Negative :
More than 200 words
( 218 )

Methods

Result

Discussion

Internal Validity

Patients Lichtenstein inguinal hernioplasty patients

Intervention non-woven polypropylene implants
Comparison heavy-weight polypropylene implants
Outcome(s) incidence of early and late
complications, recurrence rate, and postoperative
pain.

Validitas Uji

Cont internal validity

Apakah Bukti ini valid?
1

Apakah digunakan intention to treat analysis: yakni semua

pasien harus dianalisis sesuai dengan keadaan/ alokasi
awalnya tanpa melihat apakan pasien tersebut akan
menyelesaikan penelitian atau tidak.

ya

Apakah dilakukan randomisasi dan apakah daftar

randomnya disegel?Apakah RCT?

ya

Apakah klompok yang dibandingkan sebanding di awal

percobaan?

ya

Apakah blind?singel atau double blind?

ya

Apakah kelompok diperlakukan sama kecuali kelompok

yang akan diterapi untuk diteliti?

ya

Apakah semua pasien yang masuk dalam penelitian

diperhitungkan dalam simpulan akhir dan semua
dianalisis sesuai dengan keadaan awalnya?

ya

Apakah Bukti ini Penting?

1

Seberapa besarkah pengaruh terapi tersebut (Lihat NNT)

tidak

Seberapa besar persisi estimasi dari pengaruh terapi

tersebut?(Lihat CI)

Tidak

 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

pada penelitian.

tidak

Apakah terapi tersebut mungkin untuk diterapkan pada

pasien kita (dengan setting kita)

ya

Apakah pasien kita mempunyai potensi yang

menguntungkan atau merugikan jika terapi tersebut
diterapkan?

ya

Apakah nilai dan pengharapan pasien kita bila hasil penelitian

tersebut kita tawarkan untuk mengobati

ya

Apakah terapi baru tersebut tersedia?

ya

KESIMPULAN

Thank You