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Front Page Closure of the Mesenteric Defects with Clips During Laparoscopic Gastric Bypass – A Single-Centre, Single-Blinded Randomised, Controlled Trial
24 Pages Posted: 25 Jun 2020
More...Abstract
Background: Internal herniation is a well-known and potentially life-threatening complication to laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery. The aim of this study was to evaluate the benefits and disadvantages of closing the mesenteric defects with clips during LRYGB surgery in order to avoid internal herniation.
Methods: The study was a single-centre single-blinded randomised controlled trial. Patients were recruited from August 13, 2012 to May 18, 2017 and were followed for minimum 24 months. Patients were randomised to LRYGB surgery with either closure or non-closure of the mesenteric defects with clips. The primary endpoint was the incidence of internal herniation. Secondary endpoint was other postoperative complications.
Findings: A total of 401 patients were included in the study. Of these, 201 and 200 patients were randomised to closure and non-closure of the mesenteric defects, respectively. Median follow-up for both groups were 59 months. Three patients were lost for follow-up. Significantly more patients were operated for intern herniation in the non-closure group and three years after surgery, the cumulative incidence of internal herniation was 12·5% in the non-closure group versus 5·0% in the closure group (HR 2·60, 95% CI 1·25-5·41, p=0·011). Nine patients randomised to closure had severe complications (Clavien-Dindo grade IIIb) compared with five patients randomised to non-closure, p=0·416.
Interpretation: The study supports routine closure of the mesenteric defects with clips in LRYGB surgery to avoid internal herniation without increasing the risk for postoperative complications.
Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT01595230.
Funding Region Zealand research foundation and Consultant, DMSc Edgar Schnohr and wife Gilberte Schnohr’s foundation supported this project financially.
Declaration of Interests: None.
Ethics Approval Statement: The study was a single-centre single-blinded randomised controlled trial performed at Zealand University Hospital in Denmark. Approval was obtained from the Danish Data Protection Agency (SN-10-2012) and from the Regional Committee on Health Research Ethics in Region Zealand (1-01-83-0209-12, SJ-284). The study was conducted in accordance with the ethical standards of the Helsinki Declaration.
Keywords: Closure of the mesenteric defects with clips during laparoscopic gastric bypass; Internal herniation; Intermittent internal herniation; abdominal pain after closing of mesenteric defects; Preoperative and postoperative smoking
Suggested Citation: Suggested Citation