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The Search
for an Ideal Method of Abdominal Fascial Closure
A Meta-Analysis
From the Departments of *Surgery and †Epidemiology & Biostatistics,
The University of Western Ontario, London, Ontario, Canada
ANNALS OF SURGERY 2000;231:436-442
Background and Objective
The ideal suture for abdominal fascial closure has yet to be
determined. Surgical practice continues to rely largely on tradition
rather than high-quality level I evidence. The authors conducted
a systematic review and meta-analysis of randomized controlled
trials to determine which suture material and technique reduces
the odds of incisional hernia.
Methods
MEDLINE and Cochrane Library databases were searched for articles
in English published from 1966 to 1998 using the keywords “suture,”
"abdomen/surgery,” and "randomized controlled trials.” Randomized
controlled trials, trials of adult patients, and trials with a
Jadad Quality Score of more than 3, comparing suture materials,
technique, or both, were included. Two independent reviewers critically
appraised study quality and extracted data. The reviewers were
masked to the study site, authors, journal, and date to minimize
bias. The primary outcome was postoperative incisional hernia.
Secondary outcomes included wound dehiscence, infection, wound
pain, and suture sinus formation.
Results
The occurrence of incisional hernia was significantly lower when
nonabsorbable sutures were used. Suture technique favored nonabsorbable
continuous closure. Suture sinuses and wound pain were significantly
lower when absorbable sutures were used. There were no differences
in the incidence of wound dehiscence or wound infection with respect
to suture material or method of closure. Subgroup analyses of
individual sutures showed no significant difference in incisional
hernia rates between polydioxanone and polypropylene. Polyglactin
showed an increased wound failure rate.
Conclusions
Abdominal fascial closure with a continuous nonabsorbable suture
had a significantly lower rate of incisional hernia. The ideal
suture is nonabsorbable, and the ideal technique is continuous.
The ideal suture for closing abdominal fascia has yet to be determined.
Surgical tradition, prejudice, familiarity, and personal conviction
tend to dictate surgical procedures rather than evidence-based medicine.
The reported cumulative incidence of incisional hernia varies from
9% to 19%.1–3 Incisional hernias often require repair,
with postoperative recurrence rates as high as 45%,4
further contributing to complications.
Previous randomized controlled trials of abdominal fascial closure
have failed to determine the best technique and the ideal suture.
Many of these trials had small sample sizes and lacked sufficient
power to show significant treatment differences. Results were often
conflicting and have left many surgeons uncertain about the ideal
suture and technique for abdominal fascial closure.
A meta-analysis is a statistical compilation of studies performed
to address a treatment effect.5
It attempts to summarize knowledge by rigorous and explicit methodology.6
A recent meta-analysis by Weiland et al7 attempted to
address the question of fascial closure. Unfortunately, it contained
numerous omissions and raised methodologic concerns; it should therefore
be interpreted with caution. A more thorough and rigorous meta-analysis
to determine the ideal suture is warranted.
METHODS
Literature Search
Computer searches of MEDLINE for the years 1966 to 1998 and the
Cochrane Library (1998, vol. IV) database were performed using the
keywords "abdominal surgery,” "sutures,” and “randomized clinical
trials.” A manual search of the bibliographies of the identified
papers was carried out to identify any additional trials. Finally,
expert academic surgeons in Ontario, Canada, were asked whether
they knew about any important unpublished data.
Inclusion and Exclusion Criteria
All randomized clinical trials comparing at least two different
suture materials or techniques for abdominal fascial closure were
included. Trials using vertical midline, paramedian, oblique, or
transverse incisions were included. Other criteria included patients
older than 15 years and a Jadad Quality Score of more than 3.8
Gynecologic surgery trials and trials of children younger than 15
years were excluded. Trials comparing two sutures of the same category
(i.e., absorbable vs. absorbable) and with the same technique were
excluded because relevant comparisons could not be applied to our
clinical question.
Data Extraction
Two reviewers masked to journal, authors, and publication dates
performed independent data extraction. Study quality was assessed
using the Jadad Quality Scale.8 Discrepancies were resolved
by discussion and consensus.
Analyses
The primary outcome was postoperative incisional hernia. Definitions
of incisional hernia, wound dehiscence, wound infection, wound pain,
and suture sinus were accepted as reported. Based on a priori criteria,
the primary comparison was nonabsorbable versus absorbable sutures
and continuous versus interrupted techniques. Further comparisons
included continuous nonabsorbable versus continuous absorbable and
interrupted nonabsorbable versus interrupted absorbable. Studies
were assessed for homogeneity both qualitatively and quantitatively.
Statistical homogeneity of the study data was confirmed using the
chi-square test of heterogeneity.9 All analyses were
conducted using Review Manager 3.1 (Software Update, the Cochrane
Collaboration, Oxford, UK).
The Mantel-Haenszel9 fixed-effects method was used to
summarize dichotomous outcomes of pooled studies. The odds ratio
(OR) was used as the summary statistic, with 95% confidence intervals
(CI). Absolute risk reduction (ARR), relative risk reduction (RRR),
and number needed to treat (NNT) were also calculated. Sensitivity
analyses were performed by serially omitting each trial and omitting
trials with follow-up periods of less than 1 year. Comparisons of
trials using only midline incisions were also carried out. A reanalysis
using the random-effects model was also performed to assess the
robustness of the results.
Subgroup analyses of individual suture types (i.e., polydioxanone
[PDS] vs. polypropylene [Prolene]) were also conducted.
RESULTS
Thirty-two studies that evaluated suture material or technique
for abdominal fascial closure were identified. Nineteen trials were
excluded for the following reasons: poor quality,10–19
gynecologic surgery only,20,21 pediatric trial,22
nonrandomized trials,23–26 and comparison exclusions
(i.e., studies assessing absorbable vs. absorbable sutures).2,27,28
Study characteristics are displayed in Table 1. No unpublished data
were identified. Data extraction revealed no interobserver variation,
with 100% agreement between the two reviewers for all outcomes.
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Table 1. SUMMARY OF TRIALS
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Nonabsorbable Versus Absorbable
The clinical homogeneity of included trials was confirmed, with
the possible exception of one trial that compared polydioxanone
and polypropylene in morbidly obese patients.29 The test
for heterogeneity was not significant (chi-square = 21.16, P
> .05), indicating that the studies were homogenous and statistical
combination was appropriate. The pooled OR for all outcomes comparing
nonabsorbable versus absorbable sutures (13 studies)28–41
are summarized in Figure 1. An OR less than 1 favors nonabsorbable
and an OR more than 1 favors absorbable. For the primary outcome,
incisional hernia, the OR was 0.68 (95% CI 0.52–0.87; Fig. 2).
This means that the odds of incisional hernia were significantly
lower in the nonabsorbable group, by 32%. The calculated cumulative
incidence of incisional hernias across all studies was 5%.
The OR of wound infection in the nonabsorbable group versus the
absorbable group was 0.90 (95% CI 0.73–1.12) and the OR of wound
dehiscence was 1.25 (95% CI 0.78–2.01). Neither was statistically
significant. Suture sinuses and wound pain were significantly more
frequent in the nonabsorbable group (OR 2.18, 95% CI 1.48–3.22,
and OR 2.05, 95% CI 1.52–2.77, respectively).
Continuous Versus Interrupted
In the six trials comparing continuous versus interrupted technique
(irrespective of suture type), the OR for incisional hernia was
significant, favoring continuous closure (OR 0.73, 95% CI 0.55–0.99;
Fig. 3). There was no statistical difference in the rate of wound
infection or wound dehiscence.
Continuous Nonabsorbable Versus Continuous Absorbable
In the nine trials comparing continuous nonabsorbable versus continuous
absorbable suture technique (Fig. 4), incisional hernias were significantly
less common in the continuous nonabsorbable group (OR 0.61, 95%
CI 0.46–0.80; Table 2 ).
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Table 2. CLINICAL OUTCOME MEASURES OF INCISIONAL
HERNIA ACROSS COMPARISON GROUPS
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Interrupted Nonabsorbable Versus Interrupted Absorbable
There was no significant difference in incisional hernia rates
between these two trials.
Sensitivity Analyses
A reanalysis of only the trials using vertical midline incisions
(omitting trials using paramedian, transverse incisions) found that
the rate of incisional hernia was still significantly lower in the
nonabsorbable group (OR 0.64, 95% CI 0.48–0.86). Further sensitivity
analyses included reanalyzing the data using the random-effects
model, including poor-quality trials, including gynecologic trials,
excluding small trials, excluding the obesity trial, and omitting
all trials with less than 1 year of follow-up. These analyses did
not substantially change the summary statistic.
Subgroup Analyses
The subgroup analyses are summarized in Table 3. Polydioxanone
(PDS) compared with polypropylene (Prolene) did not have an increased
risk of incisional hernia (OR 1.53, CI 0.50–4.72). In contrast,
use of polyglactin (Vicryl) compared with nonabsorbable sutures
resulted in an increased rate of wound failure. Nylon compared with
polyglycolic acid (Dexon) demonstrated a lower rate of incisional
hernia (OR 0.30, 95% CI 0.13–0.68). There was no statistical difference
between polyglycolic acid (Dexon) and polypropylene (Prolene).
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Table 3. SUBGROUP ANALYSIS OF INDIVIDUAL SUTURE
TYPES
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DISCUSSION
Incisional hernias contribute significantly to the complication
rate and once repaired have a high recurrence rate.4
Wound dehiscence, infection, pain, and suture sinus formation are
also important contributors to postoperative complications.
A meta-analysis, when it includes a series of satisfactory trials
and when it is rigorously performed, provides high-quality level
I evidence. The recent meta-analysis by Weiland et al7
failed to meet most of the methodologic requirements supported by
a recent consensus.6 The search strategy was less than
explicit, nonrandomized trials, and poor-quality studies were included
in their analyses, decreasing the validity of their results. The
quality of the randomized controlled trials included in their analysis
was not assessed. Interpretation of their results was difficult
because individual study characteristics were not described. There
was an absence of clinically useful outcome measures: OR, NNT, and
RRR figures were not reported. The method of combining probability
values used in their report has two important drawbacks: it does
not weigh the studies according to their uncertainties or sample
sizes, and it does not give estimates of the magnitude of the effects.
For these reasons, combining probability values is seldom used as
a metanalytic tool.42
Poor-quality surgical trials appear to be common.43
A recent meta-analysis of drainage of colorectal anastomoses also
reported overall poor quality of the surgical trials included in
their analyses.44 The Jadad Quality Scale8
is the only validated instrument available to assess the quality
of randomized controlled trials. Incorporation of poor-quality trials
into a meta-analysis has been shown to increase the estimate of
benefit by 34% and may produce discordant results.45
In our review, 10 trials (31%) were excluded for poor quality (Jadad
score <3) to assess adequately any benefit of intervention.
In our review, qualitative and quantitative homogeneity was confirmed
and statistical combination was appropriate. Multiple sensitivity
analyses confirmed the robustness of our summary statistic. Inclusion
or exclusion of the morbidly obese trial did not alter the results.
Gynecologic trials20,21 were omitted to focus results
to a general surgical practice, and inclusion of these trials did
not appreciably change the summary statistic.
The pooled OR for incisional hernia in the nonabsorbable versus
absorbable suture groups, the primary outcome for this study, was
0.68 (95% CI 0.52–0.87). The fact that the point estimate was
less than 1 favored the nonabsorbable group (Fig. 2), a statistically
significant result. Clearly, the evidence supports a significant
benefit in using nonabsorbable suture. With an RRR of 32%, using
a nonabsorbable suture lowers the risk of incisional hernia formation
by 32%. A more clinically useful measure is NNT: the NNT was 50,
which means only 50 patients need to undergo nonabsorbable fascial
closure to prevent one incisional hernia.
For continuous nonabsorbable versus continuous absorbable, the
RRR was even greater (36%), and the NNT was 40 patients. These results
are also biologically plausible: nonabsorbable sutures retain tensile
strength for the duration of fascial healing.4 Continuous
suture technique also has the added benefit of being easier and
less time-consuming.33
A potential benefit of meta-analysis is the ability to perform
subgroup analyses.46 Our subgroup analyses demonstrated
that polydioxanone (PDS), unlike all other absorbable sutures, did
not have an increased risk of incisional hernia. Polyglactin (Vicryl)
appeared to have a significant risk of incisional hernia when compared
with nonabsorbable sutures.
Our meta-analysis is limited by the absence of unpublished literature
and possibly other sources of heterogeneity. Unpublished studies
are more likely to have “negative results”; therefore, a meta-analysis
of only published studies may have some publication bias. A survey
of experts in Ontario yielded no unpublished data. Extraction bias
was minimized by masking reviewers to publication date, authors,
and journal. Other sources of heterogeneity include patient factors
(malignancy, steroid use, pulmonary disease, obesity, age), local
factors (emergency surgery, degree of contamination, antibiotic
prophylaxis), and technical factors (surgical experience, type of
incision). These factors may theoretically have been unequally distributed
between treatment groups or between studies. Type of incision may
be instrumental in incisional hernia formation. A prospective study
described lower incisional hernia rates in paramedian incisions
versus midline incisions.28 Studies of transverse incisions
have been inconclusive.47–50 The randomized trials
included in this study did not stratify based on type of incision.
For example, no direct comparisons of midline versus transverse
incisions were done. The question of the role of incision type in
the development of incisional hernias is therefore impossible to
answer by this meta-analysis.
The follow-up of patients for individual studies was highly variable:
only seven (54%) studies followed patients for 1 year or more. This
may explain why our cumulative incidence of incisional hernia across
studies was only 5%. This incisional hernia rate at 1 year does
not reflect the true incidence of this outcome. Mudge and Hughes1
followed up a cohort of patients prospectively for 10 years and
noted that 35% of all incisional hernias occurred after 3 years.
This meta-analysis serves to synthesize some of the information
on the effect of suture choice on wound failure. It is hypothesis-generating
in that, given the high number of poor-quality trials, short follow-up,
and variable patient factors, a large definitive trial of nonabsorbable
continuous closure versus the current surgical practice with a longer
follow-up period is warranted. Because incisional hernia is an infrequent
outcome, very large sample sizes are required to determine a difference
between suture materials (nonabsorbable vs. absorbable) or technique
(continuous vs. interrupted). If we assume an incisional hernia
rate of 10% in a control group and we would like to reduce this
rate to 8% (20% RRR) in the intervention group with 80% power and
a significance level of 5%, we would require 3,206 patients in each
treatment arm in a traditional randomized controlled trial. Such
a trial seems improbable and supports doing this meta-analysis of
current trials.
In conclusion, we report high-quality level I evidence that the
ideal suture in reducing incisional hernia rates is a nonabsorbable
suture material and a continuous technique.
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Correspondence: R.A. Malthaner, MSc, MD, FACS, Department of
Thoracic Surgery, London Health Sciences Centre, 375 South St.
Suite 3N345, Victoria Campus, London, Ontario N6A 4G5, Canada.
Accepted for publication June 25, 1999.
Ann Surg 2000 March;231(3):436-442
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