Page 49 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

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 dehiscence after midline laparotomy, those who had undergone abdominal surgery through a midline incision within the past 3 months, those who were pregnant, or those who had participated in another intervention trial. The study protocol was approved by the institutional review board of Erasmus University Medical Center, Rotterdam, and by the review boards of each study centre before start of inclusion. All participants gave written informed consent. An independent data and safety monitoring board was constituted before the start of the trial. This board consisted of two independent surgeons and one biomedical statistician. All serious adverse events, de ned as death and burst abdomen that happened during the study, were reported to the institutional review board of Erasmus University Medical Center. The progress of the trial and all adverse events were reported every 3 months to the data and safety monitoring board and the safety of the trial was examined.
Randomisation and masking
After provision of consent, patients were registered in an online database in which they were assigned a unique trial code. During surgery, about 15 min before closure, patients 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 (control group), for fascial closure. Randomisation was strati ed by centre and between surgeons and residents with a minimisation procedure to ensure balance within each group and overall. Patients and study investigators were masked to group allocation. The data and safety monitoring board had access to unmasked data whenever deemed necessary.
Procedures
The principle of the small bites technique constituted placement of at least twice as many stitches as the incision length in cm with USP 2-0 PDS Plus II (Ethicon, Somerville, NJ, USA) with a 31 mm needle(10, 13-15). The suture technique was applied with tissue bites of 5 mm and intersuture spacing of 5 mm. In all cases the stitch incorporated the aponeurosis only and incorporation of fat or
3
STITCH trial
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