Volume 343:392-398 August 10, 2000Number 6

A Comparison of Suture Repair with Mesh Repair

for Incisional Hernia
Roland W. Luijendijk, M.D., Ph.D., Wim C.J. Hop, Ph.D., M. Petrousjka van
den Tol, M.D., Diederik C.D. de Lange, M.D., Marijel M.J. raaksma, M.D.,
Jan !.M. "J#ermans, M.D., Ph.D., Roelo$ %. oelhou&er, M.D., Ph.D., as C.
de 'ries, M.D., Ph.D., Mar( ).M. *alu, M.D., Ph.D., Ja(k C.J. Wereldsma,
M.D., Ph.D., Cornelis M.+. ruijnin(k,, M.D., Ph.D., and Johannes Jeekel,
M.D., Ph.D.
ABSTRACT
Background Incisional hernia is an important complication of

abdominal surgery.
Procedures for the repair of these hernias

with sutures and with mesh have been
reported, but there is

no consensus about which type of procedure is best.

Methods Between March 1992 and ebruary 199!, we performed a

multicenter
trial in which we randomly assigned to suture repair

or mesh repair 2"" patients
who were scheduled to undergo repair

of a primary hernia or a first recurrence of
hernia at the site

of a vertical midline incision of the abdomen of less than #

cm in
length or width. $he patients were followed up by physical

e%amination at 1, #,
12, 1!, 2&, and '# months. (ecurrence rates

and potential ris) factors for
recurrent incisional hernia were

analy*ed with the use of life+table methods.

Results ,mong the 1-& patients with primary hernias and the

2. patients with
first+time recurrent hernias who were eligible

for the study, -# had recurrences
during the follow+up period.

$he three+year cumulative rates of recurrence among
patients

who had suture repair and those who had mesh repair were &'

percent
and 2& percent, respectively, with repair of a primary

hernia /P0"."21 difference,
19 percentage points1 9- percent

confidence interval, ' to '- percentage points2.
$he recurrence

rates were -! percent and 2" percent with repair of a first
recurrence of hernia /P0".1"1 difference, '! percentage points1

9- percent
confidence interval, 31 to .! percentage points2.

$he ris) factors for recurrence
were suture repair, infection,

prostatism /in men2, and previous surgery for
abdominal aortic

aneurysm. $he si*e of the hernia did not affect the rate of
recurrence.

Conclusions ,mong patients with midline abdominal incisional

hernias, mesh
repair is superior to suture repair with regard

to the recurrence of hernia,
regardless of the si*e of the hernia.

Incisional hernia is a frequent complication of abdominal surgery.

In prospective studies
with sufficient follow-up, primary incisional

hernia occurred in 11 to 20 percent of
patients who had undergone

laparotomy.
1,2,3
uch hernias can cause serious morbidity,
such

as incarceration !in " to 1# percent of cases$
%,#
and strangulation

!in 2 percent$.
%
If the
hernia is not reduced promptly, small

bowel that is strangulated in the hernia may
become ischemic

and necrotic and perforation may ultimately occur. &lthough

many
techniques of repair have been described, the results are

often disappointing. &fter
primary repair, rates of recurrence

range from 2% percent to #% percent.
%,",',(,)
*epairs that
include

the use of mesh to close the defect have better but still high

recurrence rates, up to
3% percent.
(,10
&fter repair of recurrent

incisional hernias, recurrence rates of up to %(
percent have

been reported.
#
+hese studies of suture repairs and mesh repairs,

however,
were either uncontrolled or nonrandomi,ed, and it remains

uncertain whether mesh repair
is superior to suture repair.

+o define the indications for the use of mesh materials, we
undertoo- a randomi,ed, multicenter study of patients with midline

abdominal incisional
hernias.

Methods
Stud !esign
.etween /arch 1))2 and 0ebruary 1))(, we randomly assigned 200

adult patients who
were scheduled to undergo repair of a primary

hernia or a first recurrence of hernia at
the site of a vertical

midline incision to suture repair or mesh repair, after stratification
according to the type of hernia and the hospital. +he preoperative

length or width of the
fascial defect was not to e1ceed " cm,

and patients could be enrolled only once. 21clusion
criteria

were the presence of more than one hernia, signs of infection,

prior hernia repair
with mesh, and plans to repair the hernia

as part of another intraabdominal procedure.
+he study was approved

by the ethics committees of the participating hospitals, and

all
the patients gave informed consent after a physician told

them about the details of the
trial.

+he patient-related factors of se13 age3 presence or absence

of obesity, cough,
constipation, prostatism, diabetes mellitus,

glucocorticoid therapy3 smo-ing status3 and
abdominal surgical

history were recorded. 4besity was defined as a body-mass inde1

!the
weight in -ilograms divided by the square of the height

in meters$ of at least 30. 0actors
related to the operation,

including the surgical technique and the presence or absence

of
hematoma, dehiscence, and infection, were also analy,ed.

5ound infection was defined
by the discharge of pus from the

wound, evaluated up to the one-month visit. 5e also
recorded

factors related to the hernia, such as whether the hernia was

primary or a first
recurrence, the preoperative and intraoperative

si,e of the hernia, and the e1act location
of the hernia !the

upper median, 3 cm or less pro1imal or distal to the umbilicus,

or the
lower median$.

&t the onset of anesthesia, a cephalosporin was administered

intravenously. In the patients
assigned to undergo repair with

sutures, the two edges of the fascia were appro1imated in
the

midline, usually with a continuous polypropylene suture !6rolene

no. 1, 2thicon,
&mersfoort, the 7etherlands$ with stitch widths

!tissue bites$ and intervals of
appro1imately 1 cm. In the patients

assigned to undergo repair with use of mesh, the
dorsal side

of the fascia ad8acent to the hernia was freed from the underlying

tissue by at
least % cm. & polypropylene mesh !/arle1 9.ard

.enelu1, 7ieuwegein, the 7etherlands:
or 6rolene$ was tailored

to the defect so that at least 2 to % cm of the mesh overlapped

the
edges of the fascia, and the mesh was sutured to the bac-

of the abdominal wall 2 to % cm
from the edge of the defect

with a continuous suture !6rolene no. 1$. +o minimi,e contact
between the mesh and the underlying organs, any peritoneal defect

was closed or the
omentum was sutured in between. 5hen this

could not be done, a polyglactin )10
!;icryl, 2thicon$ mesh

was fi1ed in between. +he fascial edges were not closed over

the
prosthesis unless a completely tension-free repair could

be performed. <rainage and
closure of the subcutis and closure

of the cutis were optional. +he duration of surgery and
the

hospital stay was noted.

+he patients were evaluated by physicians 1, ", 12, 1(, 2%,

and 3" months after surgery.
6atients= awareness of any recurrence

of the hernia and concern about the scar were
noted. 5hen patients

were as-ed whether they had pain, their responses were recorded

as
simply >yes> or >no.> +he scar was e1amined for recurrence

of hernia, which was
defined as any fascial defect that was

palpable or detected by ultrasound e1amination and
was located

within ' cm of the site of hernia repair. +he e1amination included

palpation
while the patient was in the supine position with

legs e1tended and raised. ?ltrasound
e1aminations were performed

only when physical e1aminations were not definitive.

Statisti"al Analsis
6ercentages and continuous variables were compared with the

use of 0isher=s e1act test
and the /ann@5hitney test,

respectively. +he cumulative percentages of patients with
recurrences

over time were calculated and compared with use of Aaplan@/eier

curves
and log-ran- tests. /ultivariate analysis of various

factors was performed with Bo1
regression analysis. +hrough

the use of appropriate interaction terms, we investigated
whether

the effect of treatment depended on the si,e of the repaired

hernia. &ll statistical
tests were two-sided. +he primary analysis

was performed on an intention-to-treat basis3
that is, patients

remained in their assigned group even if during the procedure

the surgeon
8udged the patient not to be suitable for the technique

assigned. & per-protocol analysis,
which e1cluded patients with

ma8or protocol violations, was also performed.

Results
&mong the 200 patients enrolled in the study, 1'1 had a primary

incisional hernia, and
2) had a first recurrence of incisional

hernia. eventeen patients in the former group and
two in the

latter group were found to be ineligible for the study, for

the following reasonsC
no incisional hernia was evident intraoperatively

!nine patients$, the operation was
canceled !five patients$,

no follow-up data were obtained !three patients$, hernia repair
was part of another procedure !one patient$, or herniation was

too close to an
enterostomy for the specified procedure to be

performed !one patient$. &t base line, the
patients assigned

to the mesh-repair group were slightly younger and had a higher
frequency of past surgery for abdominal aortic aneurysm, whereas

there were more
patients with prostatism in the suture-repair

group !+able 1$.

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$able 1% .ase-Dine Bharacteristics of the 6atients with Incisional
&ernia, &ccording to tudy Eroup.

+he recurrence rates for the two groups, subdivided according

to whether the patients had
a primary hernia or a first recurrence,

are shown in +able 2. &mong the patients with
primary hernias,

(0 were assigned to suture repair and '% to mesh repair !( with

an
additional polyglactin )10 9;icryl: mesh$. +he mean duration

of follow-up was 2"
months !range, 1 to 3"$ for patients without

recurrence and was similar for both treatment
groups. +hirty-two

patients !1" in each group$ were lost to follow-upC ' patients

died
!none within 1 month after surgery$3 # underwent further

surgery through the repair at a
later date3 1 moved abroad3

and 1) did not appear at their ne1t appointment for various
reasons, such as wor- or immobility !mean follow-up, 10 months$.

+hese 32 patients
were included in the analysis, but follow-up

data were censored at the time of their last
contact with the

investigators or at the time of reoperation.

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$able 2% *ates of *ecurrence &ccording to 5hether the *epaired
Incisional &ernia 5as 6rimary or a 0irst *ecurrence.

even patients assigned to the suture-repair group underwent

mesh repair, and five
patients assigned to the mesh-repair group

underwent suture repair3 one patient in each
group had a recurrence.

In all patients who had been assigned to the suture-repair group
but underwent mesh repair, the surgeon 8udged that the defect

was too large !all were
more than 3" cm
2
$ to be repaired without

adding a prosthesis for strength. 4f the patients
assigned to

the mesh-repair group who underwent suture repair, two represented
violations of the protocol and two underwent suture repair because

the surgeon deemed
the defect too small for mesh repair. In

one case the ris- of infection of the planned mesh
repair was

8udged to be high because of an inadvertent enterotomy. &mong

patients with
primary hernias, the three-year cumulative rates

of recurrence were %3 percent for those
who underwent suture

repair and 2% percent for those who underwent mesh repair
!6F0.02$

!+able 2$.

4f the patients with first recurrences, 1' were assigned to

suture repair and 10 were
assigned to mesh repair. +wo patients

assigned to the suture-repair group underwent mesh
repair because

the surgeon 8udged the defect to be too large !more than 3"

cm
2
$ for repair
without a prosthesis !one patient had a recurrence$.

+he mean duration of follow-up was
30 months !range, 1 to 3"$

for patients without recurrence and was similar for both
treatment

groups. +he three-year cumulative rates of recurrence in the

suture-repair and
mesh-repair groups were #( percent and 20

percent, respectively !6F0.10$ !+able 2$.

5hen both hernia groups were combined, the mean duration of

follow-up was 2" months
!range, 1 to 3"$ for patients without

recurrence and was similar for both treatment groups
!6F0.00#$

!+able 2 and 0igure 1$. +he three-year cumulative rates of recurrence

were %"
percent with suture repair and 23 percent with mesh

repair. In the subgroup of #0 patients
with small hernias !10

cm
2
or smaller$, the three-year cumulative rate of recurrence

after
suture repair was %% percent, as compared with " percent

in the mesh-repair group
!6F0.01$.

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(igure 1% Aaplan@/eier Burves for *ecurrence of
&ernia after *epair of a 6rimary or 0irst *ecurrent
Incisional &ernia, &ccording to 5hether the 6atient
5as &ssigned to /esh *epair !7F(%$ or uture *epair
!7F)'$.
+here were significantly fewer recurrences in patients
who were assigned to mesh repair !6F0.00#$.

+he median duration of the operation was %# minutes !range,

1# to 13#$ for suture repair
and #( minutes !range, 1# to 1#0$

for mesh repair !6F0.0)$. +he median length of the
hospital

stay was " days !range, 1 to 3'$ for suture repair and # days

!range, 1 to 1#$ for
mesh repair !6F0.%%$.

)er-)roto"ol Analsis
In the total group of 1(1 patients, ma8or violations of the

protocol occurred in the repairs
of # patients. In one patient,

the most pro1imal of four hernias found intraoperatively was
repaired with use of a prosthesis and the other three hernias

were repaired with sutures.
In another patient, the fascial

defect was sutured under a subcutaneous mesh repair. In the
third patient, several intraoperatively discovered wea- spots

were not completely covered
by subcutaneous mesh repair !for

un-nown reasons$, ma-ing recurrence inevitable. +he
other two

patients were switched to suture repair despite the fact that

a mesh repair could
have been performed with ease, according

to the operative notes !one patient had a
recurrence$. 5ith

data on these five patients removed from the analysis, the three-year
cumulative rates of recurrence in the suture-repair group !)#

patients$ and mesh-repair
group !(1 patients$ were similar to

those in the intention-to-treat analysis G namely, %"
percent and 23 percent, respectively !6F0.00#$.

*e"urren"es a+ter ,esh *e-air
5e attempted to determine the reasons for recurrence in all

patients who underwent mesh
repair, regardless of treatment

assignment !e1cluding repairs that were deemed to reflect
ma8or

trial violations$. 6ossible e1planations were that the mesh

was attached with 2 cm
or less of overlap !five patients$, that

interrupted sutures were placed 2 cm apart !one
patient$, that

mar-ed abdominal distention occurred during the first wee- after

surgery
!one patient$, that recurrence resulted from glucocorticoid

therapy !one patient$, that it
resulted from infection of a

large hematoma !one patient$, and that the repair was
inadequate

because the patient had pain during the procedure as a result

of inadequate
epidural anesthesia !one patient$. 7o e1planation

for recurrence was found in the cases of
seven patients who

had undergone mesh repair.

Analsis o+ )rognosti" (a"tors
In the univariate analysis, prostatism !in men$, a history of

surgery for abdominal aortic
aneurysm, and infection were identified

as ris- factors for recurrence !data not shown$.
+he results

of the multivariate analysis of these factors together with

the type of repair,
age, si,e of hernia, and primary hernia

or first recurrence of hernia are shown in +able
3. In this

analysis, suture repair, infection, prostatism !in men$, and

history of surgery for
abdominal aortic aneurysm were all identified

as independent ris- factors for recurrence.
&fter ad8ustment

for the other factors, mesh repair was found to result in a

#' percent
lower rate of recurrence !)# percent confidence interval,

1) to '' percent3 6F0.00)$ than
suture repair. +he difference

in rates of recurrence between the suture-repair group and
the

mesh-repair group was not affected by the si,e of the hernia.

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$able 3% *esults of /ultivariate &nalysis of 0actors &ffecting the *ates
of *ecurrence after *epair of Incisional &ernia.

.om-li"ations
4ne of the )' patients in the suture-repair group had complete

wound dehiscence after
mar-ed abdominal distention that resulted

from an ileus on the fifth day after surgery.
4ne of the (%

patients in the mesh-repair group had a recurrence associated

with intestinal
strangulation 1( months after surgery. In another

patient who underwent mesh repair,
contact with the intestines

was not adequately prevented, so one month later, at
laparotomy

performed because of a persisting ileus, two loops of small

intestine appeared
to be fi1ed to the mesh, prohibiting fecal

flow. +hree of the (% patients !% percent$ had
postoperative

infections but did not require removal of the mesh, # patients

!" percent$
had postoperative abdominal bulging, and 1 patient

!1 percent$ had postoperative
bleeding.

+he frequency of pain one month after surgery was similar in

the two treatment groups
!suture-repair group, 1) patients 920

percent:3 mesh-repair group, 1# patients 91(
percent:$. +he

pain usually disappeared after the first month. even of the

patients had
hematomas, and five had recurrent hernias. 6ostoperative

serosanguineous lea-age
occurred in three patients in the suture-repair

group and in four patients in the mesh-repair
group. &n inadvertent

enterotomy occurred in four patients !2 percent$, without later
complications. 4ther complications were suture-thread sinus

!one patient$, pneumonia
!four patients$, urinary tract infection

!three patients$, and myocardial infarction !one
patient$.

A#areness o+ *e"urren"es on the )art o+ )atients
&ll patients were as-ed before each follow-up physical e1amination

whether they had
noticed a recurrence of hernia. 4f the 13)

patients who believed they had no recurrence,
1% !10 percent$

had a recurrence, as evidenced by physical e1amination. +he

%2 patients
who believed they had a recurrence indeed had one,

as shown by e1amination. 5hen only
these self-reported recurrences

were counted, the three-year cumulative rates of
recurrence

were 3# percent for the suture-repair group and 1' percent for

the mesh-repair
group !6F0.02$.

Discussion
+he techniques used for repairing incisional hernias have generally

developed in a
practical, e1periential way. everal authors

have reported favorable results with mesh
repair,
3,(,10,11,12,13,1%,1#,1",1',1(,1)
but to date this technique has not been studied systematically.
5e now report the results of a prospective, randomi,ed, multicenter

trial in which suture
repair was compared with mesh repair3

the latter was determined to be more effective.

In techniques for the repair of incisional hernias in which

sutures are used, the edges of
the defect are brought together,

which may lead to e1cessive tension and subsequent
wound dehiscence

or incisional herniation as a result of tissue ischemia and

the cutting of
sutures through the tissues.
20
5ith prosthetic

mesh, defects of any si,e can be repaired
without tension. In

addition, polypropylene mesh, by inducing an inflammatory response,
sets up a scaffolding that, in turn, induces the synthesis of

collagen. 4ur study establishes
the superiority of mesh repair

over suture repair with regard to the recurrence of hernia.

5e too- no measures to prevent the evaluating clinicians and

patients from -nowing the
type of repair used in each case3

this might be considered a limitation of the study. +he
forms

used to record the findings of the postoperative e1aminations

did not include
information on the type of repair used, but

in 1' percent of the cases, only the surgeon
who performed the

operation evaluated the patient at follow-up. 0urthermore, in

a
thorough e1amination, the technique performed may be detected,

because after mesh
repair, a fascial rim can be palpated in

some patients with a large fascial defect.
+herefore, the e1amining

physicians may have -nown which technique was used, and
bias

on their part may have affected the outcome. However, the rate

of recurrence after
suture repair was similar to that predicted

on the basis of our previous wor-.
",21,22
&lso,
when only the

self-reported recurrences, which are li-ely to be less susceptible

to biased
ascertainment, were counted, the difference remained

significant !6F0.02$.

+he si,e of the hernia was an independent ris- factor for recurrence

in two retrospective
studies by our group, in which >appro1imating>

!edge-to-edge$ fascial repairs
",21
and
>overlapping> repairs
22
were evaluated, but not in another study.
#
In medical records,
however, the si,e of the defect is often described insufficiently,

so analyses of
retrospective data are less reliable. &lso, the

e1tent of the decrease in la1ity of the tissue
surrounding the

hernia, which is influenced by retraction of muscle and scarification

of
tissues, may be more important than the actual si,e of the

fascial defect. In this
prospective study, the si,e of the defect

was not a ris- factor for recurrence.

6atients with hernias who had undergone surgery for an abdominal

aortic aneurysm had
significantly higher recurrence rates than

patients without such a history. &n increased
frequency of primary

or recurrent inguinal and incisional hernia in patients who

have had
an aneurysm has been previously reported in some retrospective

studies but not in
others.
23,2%,2#,2",2',2(,2)
5hether an inherent

defect in healing e1ists in patients with aortic
aneurysms or

hernial disease is not -nown, but possible defects in healing

may be
e1plained by defects in collagen and elastin cross-lin-ages,
30
increased activity of elastase
with reduced content of elastin,
31
and different relative proportions of collagen
subtypes.
32,33,3%
mo-ing may also be a factor,
3#
but it was not a factor in this

study !data
not shown$.

Infection did not lead to the removal of mesh in this and most

other series,
",12,13,1#,1)
but it
was a ris- factor for recurrence.

+herefore, the administration of broad-spectrum
antibiotics

at the induction of anesthesia is recommended.
3"
4n the basis of our results, we recommend attachment of the

prosthesis to the dorsal side
of the defect with an overlap

as large as possible, and we recommend that the mesh be
sutured

to the surrounding fascia with intervals of no more than 1 to

2 cm between
stitches. .ulging must be prevented, but the mesh

should not be implanted under tension.
Bontact between the polypropylene

mesh and the viscera must be avoided because of the
ris- of

adhesions, intestinal obstruction, and fistulas.
1)
5hen the

peritoneum cannot be
closed or when omentum cannot be interposed,

polyglactin )10 !;icryl$ mesh may be
interposed to protect the

viscera,
1',3',3(
but e1perimental and clinical studies are not
conclusive with respect to the efficacy of the interposition

of the polyglactin mesh in
preventing these complications.
3(,3),%0
In conclusion, in patients with incisional hernias, retrofascial

preperitoneal repair with
polypropylene mesh is superior to

suture repair with regard to the recurrence of hernia,
even

in patients with small defects.

5e are indebted to /rs. &nne-e E. van <uuren for assistance

with data management and to the following
clinical centers and

local trial coordinators for the enrollment and follow-up of

patientsC Iie-enhuis
tuivenberg, &ntwerp, .elgium !E.6. van

der chelling, /.<.$3 tichting <eventer Iie-enhui,en, <eventer,
the 7etherlands !&.J. 0rima, /.<.$3 4osterschelde Iie-enhuis,

Eoes, the 7etherlands !B./. <i8-huis,
/.<., 6h.<.$3 tichting

Iie-enhuis &mstelveen, &mstelveen, the 7etherlands !<. van Eeldere,

/.<.,
6h.<.$3 and Holy Iie-enhuis, ;laardingen, the 7etherlands

!H.J. *ath, /.<.$.

Source Information
0rom the <epartment of 6lastic and *econstructive urgery, ?niversity Hospital ;ri8e ?niversiteit,
&msterdam !*.5.D.$3 the <epartment of 2pidemiology and .iostatistics, /edical chool, 2rasmus
?niversity, *otterdam !5.B.J.H.$3 the <epartment of Eeneral urgery, ?niversity Hospital *otterdam@
<i8-,igt, *otterdam !/.6.+., <.B.<.D., /./.J..., J.7./.IJ., J.J.$3 the <epartment of Eeneral urgery,
I-a,ia Hospital, *otterdam !*.?...$3 the <epartment of Eeneral urgery, /edisch Bentrum Haaglanden,
5esteinde Hospital, +he Hague !..B.;.$3 the <epartment of Eeneral urgery, Iuider,ie-enhuis, *otterdam
!/.A./..$3 the <epartment of Eeneral urgery, int 0ranciscus Easthuis, *otterdam !J.B.J.5.$3 and the
<epartment of Eeneral urgery, Deyenburg Iie-enhuis, +he Hague !B./.&...$ G all in the 7etherlands.
&ddress reprint requests to 6rofessor Jee-el at the <epartment of Eeneral urgery, ?niversity Hospital
*otterdam@<i8-,igt, <r. /olewaterplein %0, 301# E< *otterdam, the 7etherlands, or at spe-Khl-d.a,r.nl.
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