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
Title

Author

Five-year results of a randomised controlled

multi-centre studycomparing heavy-weight
knitted
versus
low-weight,
nonwovenpolypropylene
implants
in
Lichtenstein hernioplasty

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

Published at:

25 March 2011

Published by:

Hernia The World Journal of Hernia and

Abdominal Wall Surgery

INTRODUCTION
HERNIA
HERNIOPLASTY

Materialreduced
meshes

NON WOVEN (NW)

POLYPROPYLENE

Lichtenstein
technique
POST-OP
PROBLEM :
The recurrence
and pain rate

MESH
IMPLANTATION

Inflammatory
reaction and scar
tissue formation
caused by mesh

NOT
Documented as a reason
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

POLYPROPILANE (WN )

HEAVY WEIGHT KNITTED

POLYPROPILANE (HW)

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

METHODS

Study
Design

prospective randomised
controlled multi-centre
blinded study

Place

in four hospitals in Poland.

SAMPLE

INCLUSION

Patients diagnosed with primary inguinal

hernia who were aged between 20 and 75
years

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

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, nonwovenpolypropylene 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

Positive
Negative

Clear sample and inclusion criteria

Clear intervention among groups
Analytical studies were clearly mentioned
Outcome were clearly measured

Result

Positive

Negative

Accompanied by tables presented in accordance with

the format of International Journal Writting (without
inner vertical and horizontal lines) and serial number,
table title and description of the content
Statistical value was written

Discussion

Positive
negative

There are comparisons test of previous

studies and the theory
There mentioned drawbacks and
advantages of research results that have
been achieved
There is an emphasis if the results of the
research will be applied
Any suggestions for future research
-

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
1
the therapy study is VALID
2
the therapy study is NOT IMPORTANT
3
the therapy study is APPLICABLE

Thank You