Abstract
BackgroundPatients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.MethodsIn this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients’ postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.ResultsA total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).DiscussionBoth abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.Trial registrationDeutsches Register Klinischer Studien (www.germanctr.de): DRKS00013001
Highlights
Despite advances in minimally invasive surgery, laparotomy remains a mainstay strategy for abdominal access
Current evidence suggests that relaparotomy poses a twofold risk of incisional hernia, resulting in higher costs and a reduced quality of life [2,3,4]
Occurrence of incisional hernia decreased further; after a new suture technique, the small stitches technique was developed [6,7,8]. None of these trials addressed the population of relaparotomy patients, for which the large stitches technique is still frequently applied in clinical practice
Summary
Despite advances in minimally invasive surgery, laparotomy remains a mainstay strategy for abdominal access. Occurrence of incisional hernia decreased further; after a new suture technique, the small stitches technique was developed [6,7,8] None of these trials addressed the population of relaparotomy patients, for which the large stitches technique is still frequently applied in clinical practice. Techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. Methods In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).
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