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.
(Taken from New England Journal of Medicine.Vol.:392-8. Augu! "#$ 2###%
ABSTRACT
a(kground 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.

Con(lusions ,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 fre4uent complication of abdominal surgery.

In prospective studies
with sufficient follow+up, primary incisional

hernia occurred in 11 to 2" percent of
patients who had undergone

laparotomy. 5uch hernias can cause serious morbidity, such
as incarceration /in # to 1- percent of cases2 and strangulation

/in 2 percent2. 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 techni4ues 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 '& percent. ,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
Study Design
Between March 1992 and ebruary 199!, we randomly assigned 2""

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 e%ceed # cm,

and patients could be enrolled only once. 6%clusion
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 se%1 age1 presence or absence

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

glucocorticoid therapy1 smo)ing status1 and
abdominal surgical

history were recorded. 7besity was defined as a body+mass inde%

/the
weight in )ilograms divided by the s4uare of the height

in meters2 of at least '". actors
related to the operation,

including the surgical techni4ue and the presence or absence

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

8ound infection was defined
by the discharge of pus from the

wound, evaluated up to the one+month visit. 8e 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 e%act location
of the hernia /the

upper median, ' cm or less pro%imal or distal to the umbilicus,

or the
lower median2.

,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 appro%imated in
the

midline, usually with a continuous polypropylene suture /Prolene

no. 1, 6thicon,
,mersfoort, the 9etherlands2 with stitch widths

/tissue bites2 and intervals of
appro%imately 1 cm. In the patients

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

of the fascia ad:acent to the hernia was freed from the underlying

tissue by at
least & cm. , polypropylene mesh /Marle% ;Bard

Benelu%, 9ieuwegein, the 9etherlands<
or Prolene2 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 /Prolene no. 12. $o minimi*e contact
between the mesh and the underlying organs, any peritoneal defect

was closed or the
omentum was sutured in between. 8hen this

could not be done, a polyglactin 91"
/=icryl, 6thicon2 mesh

was fi%ed 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 '# months after surgery.
Patients? awareness of any recurrence

of the hernia and concern about the scar were noted.
8hen patients

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

as simply
@yes@ or @no.@ $he scar was e%amined for recurrence

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

palpable or detected by ultrasound e%amination and was located
within . cm of the site of hernia repair. $he e%amination included

palpation while the
patient was in the supine position with

legs e%tended and raised. Altrasound e%aminations
were performed

only when physical e%aminations were not definitive.

Statistical Analysis
Percentages and continuous variables were compared with the

use of isher?s e%act test
and the Mann38hitney test,

respectively. $he cumulative percentages of patients with
recurrences

over time were calculated and compared with use of Baplan3Meier

curves
and log+ran) tests. Multivariate analysis of various

factors was performed with Co%
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 basis1
that is, patients

remained in their assigned group even if during the procedure

the surgeon
:udged the patient not to be suitable for the techni4ue

assigned. , per+protocol analysis,
which e%cluded patients with

ma:or protocol violations, was also performed.

Results
,mong the 2"" patients enrolled in the study, 1.1 had a primary

incisional hernia, and 29
had a first recurrence of incisional

hernia. 5eventeen patients in the former group and two
in the

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

the following reasonsD no
incisional hernia was evident intraoperatively

/nine patients2, the operation was canceled
/five patients2,

no follow+up data were obtained /three patients2, hernia repair

was part of
another procedure /one patient2, or herniation was

too close to an enterostomy for the
specified procedure to be

performed /one patient2. ,t base line, the patients assigned

to
the mesh+repair group were slightly younger and had a higher

fre4uency of past surgery
for abdominal aortic aneurysm, whereas

there were more patients with prostatism in the
suture+repair

group /$able 12.


$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,

!" were assigned to suture repair and .& to mesh repair /! with

an
additional polyglactin 91" ;=icryl< mesh2. $he mean duration

of follow+up was 2#
months /range, 1 to '#2 for patients without

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

patients /1# in each group2 were lost to follow+upD . patients

died
/none within 1 month after surgery21 - underwent further

surgery through the repair at a
later date1 1 moved abroad1

and 19 did not appear at their ne%t appointment for various
reasons, such as wor) or immobility /mean follow+up, 1" months2.

$hese '2 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.

5even patients assigned to the suture+repair group underwent

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

underwent suture repair1 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 :udged that the defect

was too large /all were
more than '# cm
2
2 to be repaired without

adding a prosthesis for strength. 7f 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

:udged to be high because of an inadvertent enterotomy. ,mong

patients with
primary hernias, the three+year cumulative rates

of recurrence were &' percent for those
who underwent suture

repair and 2& percent for those who underwent mesh repair
/P0"."22

/$able 22.

7f the patients with first recurrences, 1. were assigned to

suture repair and 1" were
assigned to mesh repair. $wo patients

assigned to the suture+repair group underwent mesh
repair because

the surgeon :udged the defect to be too large /more than '#

cm
2
2 for repair
without a prosthesis /one patient had a recurrence2.

$he mean duration of follow+up was
'" months /range, 1 to '#2

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 2"

percent, respectively /P0".1"2 /$able 22.

8hen both hernia groups were combined, the mean duration of

follow+up was 2# months
/range, 1 to '#2 for patients without

recurrence and was similar for both treatment groups
/P0".""-2

/$able 2 and igure 12. $he three+year cumulative rates of recurrence

were &#
percent with suture repair and 2' percent with mesh

repair. In the subgroup of -" patients
with small hernias /1"

cm
2
or smaller2, the three+year cumulative rate of recurrence

after
suture repair was && percent, as compared with # percent

in the mesh+repair group
/P0"."12.

View larger version /-B2D
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Figure 1. Baplan3Meier Curves for (ecurrence of
Eernia after (epair of a Primary or irst (ecurrent
Incisional Eernia, ,ccording to 8hether the Patient 8as
,ssigned to Mesh (epair /90!&2 or 5uture (epair
/909.2.
$here were significantly fewer recurrences in patients
who were assigned to mesh repair /P0".""-2.

$he median duration of the operation was &- minutes /range,

1- to 1'-2 for suture repair
and -! minutes /range, 1- to 1-"2

for mesh repair /P0"."92. $he median length of the
hospital

stay was # days /range, 1 to '.2 for suture repair and - days

/range, 1 to 1-2 for
mesh repair /P0".&&2.

Per-Protocol Analysis
In the total group of 1!1 patients, ma:or violations of the

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

the most pro%imal 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 reasons2, 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
recurrence2. 8ith

data on these five patients removed from the analysis, the three+year
cumulative rates of recurrence in the suture+repair group /9-

patients2 and mesh+repair
group /!1 patients2 were similar to

those in the intention+to+treat analysis F namely, &#
percent and 2' percent, respectively /P0".""-2.

Recurrences after Mesh Repair
8e attempted to determine the reasons for recurrence in all

patients who underwent mesh
repair, regardless of treatment

assignment /e%cluding repairs that were deemed to reflect
ma:or

trial violations2. Possible e%planations were that the mesh

was attached with 2 cm
or less of overlap /five patients2, that

interrupted sutures were placed 2 cm apart /one
patient2, that

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

surgery
/one patient2, that recurrence resulted from glucocorticoid

therapy /one patient2, that it
resulted from infection of a

large hematoma /one patient2, and that the repair was
inade4uate

because the patient had pain during the procedure as a result

of inade4uate
epidural anesthesia /one patient2. 9o e%planation

for recurrence was found in the cases of
seven patients who

had undergone mesh repair.

Analysis of Prognostic Factors
In the univariate analysis, prostatism /in men2, a history of

surgery for abdominal aortic
aneurysm, and infection were identified

as ris) factors for recurrence /data not shown2.
$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 '.
In this

analysis, suture repair, infection, prostatism /in men2, and

history of surgery for
abdominal aortic aneurysm were all identified

as independent ris) factors for recurrence.
,fter ad:ustment

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

-. percent
lower rate of recurrence /9- percent confidence interval,

19 to .. percent1 P0".""92 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.


o!plications
7ne of the 9. 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.
7ne 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 ade4uately prevented, so one month later, at
laparotomy

performed because of a persisting ileus, two loops of small

intestine appeared
to be fi%ed to the mesh, prohibiting fecal

flow. $hree of the !& patients /& percent2 had
postoperative

infections but did not re4uire removal of the mesh, - patients

/# percent2
had postoperative abdominal bulging, and 1 patient

/1 percent2 had postoperative
bleeding.

$he fre4uency of pain one month after surgery was similar in

the two treatment groups
/suture+repair group, 19 patients ;2"

percent<1 mesh+repair group, 1- patients ;1!
percent<2. $he

pain usually disappeared after the first month. 5even of the

patients had
hematomas, and five had recurrent hernias. Postoperative

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 percent2, without later
complications. 7ther complications were suture+thread sinus

/one patient2, pneumonia
/four patients2, urinary tract infection

/three patients2, and myocardial infarction /one
patient2.

Awareness of Recurrences on the Part of Patients
,ll patients were as)ed before each follow+up physical e%amination

whether they had
noticed a recurrence of hernia. 7f the 1'9

patients who believed they had no recurrence,
1& /1" percent2

had a recurrence, as evidenced by physical e%amination. $he

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

as shown by e%amination. 8hen only
these self+reported recurrences

were counted, the three+year cumulative rates of
recurrence

were '- percent for the suture+repair group and 1. percent for

the mesh+repair
group /P0"."22.

Discussion
$he techni4ues used for repairing incisional hernias have generally

developed in a
practical, e%periential way. 5everal authors

have reported favorable results with mesh
repair,

but to date this techni4ue has not been studied systematically.

8e now report the
results of a prospective, randomi*ed, multicenter

trial in which suture repair was
compared with mesh repair1

the latter was determined to be more effective.

In techni4ues for the repair of incisional hernias in which

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

which may lead to e%cessive tension and subse4uent
wound dehiscence

or incisional herniation as a result of tissue ischemia and

the cutting of
sutures through the tissues. 8ith 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. 7ur study establishes
the superiority of mesh repair

over suture repair with regard to the recurrence of hernia.

8e too) no measures to prevent the evaluating clinicians and

patients from )nowing the
type of repair used in each case1

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

used to record the findings of the postoperative e%aminations

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. urthermore, in

a
thorough e%amination, the techni4ue performed may be detected,

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

some patients with a large fascial defect.
$herefore, the e%amining

physicians may have )nown which techni4ue was used, and
bias

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

of recurrence after
suture repair was similar to that predicted

on the basis of our previous wor). ,lso, when
only the

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

to biased
ascertainment, were counted, the difference remained

significant /P0"."22.

$he si*e of the hernia was an independent ris) factor for recurrence

in two retrospective
studies by our group, in which @appro%imating@

/edge+to+edge2 fascial repairs and
@overlapping@ repairs

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

e%tent of the decrease in la%ity 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.

Patients with hernias who had undergone surgery for an abdominal

aortic aneurysm had
significantly higher recurrence rates than

patients without such a history. ,n increased
fre4uency 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.
8hether an inherent

defect in healing e%ists in patients with aortic aneurysms or

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

may be e%plained by defects in
collagen and elastin cross+lin)ages,

increased activity of elastase with reduced content of
elastin,

and different relative proportions of collagen subtypes.

5mo)ing may also be a
factor, but it was not a factor in this

study /data not shown2.

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

other series, but it was a
ris) factor for recurrence.

$herefore, the administration of broad+spectrum antibiotics

at
the induction of anesthesia is recommended.

7n 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. Bulging must be prevented, but the mesh

should not be implanted under tension.
Contact between the polypropylene

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

adhesions, intestinal obstruction, and fistulas. 8hen the

peritoneum cannot be
closed or when omentum cannot be interposed,

polyglactin 91" /=icryl2 mesh may be
interposed to protect the

viscera, but e%perimental and clinical studies are not

conclusive
with respect to the efficacy of the interposition

of the polyglactin mesh in preventing
these complications.

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.

8e are indebted to Mrs. ,nne)e G. van >uuren for assistance

with data management and
to the following clinical centers and

local trial coordinators for the enrollment and follow+
up of

patientsD Hie)enhuis 5tuivenberg, ,ntwerp, Belgium /G.P. van

der 5chelling, M.>.21
5tichting >eventer Hie)enhui*en, >eventer,

the 9etherlands /,.I. rima, M.>.21
7osterschelde Hie)enhuis,

Goes, the 9etherlands /C.M. >i:)huis, M.>., Ph.>.21 5tichting