Elsevier

The Lancet

Volume 386, Issue 10000, 26 September–2 October 2015, Pages 1254-1260
The Lancet

Articles
Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial

https://doi.org/10.1016/S0140-6736(15)60459-7Get rights and content

Summary

Background

Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions.

Methods

We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052.

Findings

Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31–0·87; p=0·0131). Rates of adverse events did not differ significantly between groups.

Interpretation

Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions.

Funding

Erasmus University Medical Center and Ethicon.

Introduction

Incisional hernia is a frequent complication of abdominal operations with an incidence of 10–23%, which can increase to 38% in specific risk groups.1, 2, 3, 4 In the USA 4 million to 5 million laparotomies are done annually, suggesting that at least 400 000–500 000 incisional hernias can be expected to occur every year. Incisional hernia is associated with pain and discomfort, resulting in a decreased quality of life.5 Moreover, incarceration and strangulation of abdominal contents can take place, for which emergency surgery is indicated, with associated morbidity and mortality.6 About 348 000 operations for incisional hernia are done every year in the USA with US$3·2 billion in annual associated costs.7 Prevention of incisional hernia is therefore of paramount importance.

Several suturing techniques for abdominal closure after a midline abdominal incision have been studied in the past few decades. Findings from meta-analyses have shown that a running technique with long-lasting monofilament suture material reduces the incidence of incisional hernia compared with interrupted suture techniques.3, 8 Nowadays, most surgeons, urologists, and gynaecologists use the running closure technique with large tissue bites to close midline incisions.9 In 2009, a study from Sweden10 showed that a running suture technique with small tissue bites, developed by Israelsson, decreased the incidence of incisional hernia compared with a running suture technique with large tissue bites. In this study, small tissue bites were defined as placement of a stitch every 5–8 mm from the wound edge. This promising technique is contradictory to old surgical principles and needs to be thoroughly investigated before it can be widely implemented.11, 12

Research in context

Evidence before this study

Incisional hernia is a frequent complication of abdominal operations with an incidence of more than 10%, which can increase to 38% in specific risk groups. Findings from meta-analyses have shown that a running technique with long-lasting monofilament suture material reduced the incidence of incisional hernia compared with interrupted suture techniques. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials up to and Dec 29, 2014, with the search terms “Large OR small OR long OR short”, “suture OR sutures OR stitch”, “midline incision OR median laparotomy”, “randomized controlled trial” to identify randomised controlled trials comparing small bites with large bites for closure of the abdominal fascia after midline laparotomy for prevention of incisional hernia. We manually cross-searched the reference lists of the retrieved reports for additional publications. Only one randomised controlled trial was identified comparing small tissue bites with large tissue bites. This quasi-randomised single-centre study showed that a running suture technique with small tissue bites decreased the incidence of incisional hernia compared with a running suture technique with large tissue bites.

Added value of this study

Our findings confirm the effectiveness of the small bites suture technique for prevention of incisional hernia. The small bites technique was not associated with more pain or adverse events than the large bites technique.

Implications of all the available evidence

Our findings and those from the previous quasi-randomised controlled trial of small versus large bites provide strong evidence supporting closure of an abdominal midline incision with a continuous small bite suture technique with at least twice as many small stitches as the incision length in cm. The small bites suture technique should be considered as the standard closure technique for midline incisions.

We did the STITCH study to compare the common conventional large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions.

Section snippets

Study design

We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. The trial protocol has been previously published.13 Patients aged 18 years or older and scheduled to undergo elective abdominal surgery through a midline incision were asked to participate in the trial at the outpatient clinic or in hospital on the day before surgery. We excluded patients with a history of incisional hernia or fascial

Results

The figure shows the trial profile. Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=248) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) completed follow-up and were included in the primary outcome analysis (figure). Baseline characteristics were similar between groups, except that slightly more patients with COPD were included in the small bites group (table 1). Most surgical procedures were for

Discussion

Our findings show that suturing of the fascia after abdominal midline incision with a continuous small bites technique reduces the incidence of incisional hernia compared with suturing with the conventional large bites technique. The small bites technique with a single suture USP 2-0 is a safe technique in view of the low incidence of burst abdomen, and is easily learnt and performed with the small needle.14 With a mean additional closure time of 4 min, the small bites technique is not very

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