Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia
Sara Danshøj Kristensen, Lars Naver, Per Jess, Andrea Karen Floyd, Sara Danshøj Kristensen, Lars Naver, Per Jess, Andrea Karen Floyd
Abstract
Introduction: The aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass to avoid internal herniation (IH).
Material and methods: The study is performed as a single-centre, randomised, controlled, blinded trial. Patients are randomly assigned to either conventional laparoscopic Roux-en-Y gastric bypass (LRYGB) without closing the mesenteric defects (n = 250) or RYGB with closing of the defects with hernia clips (n = 250). Follow-up is conducted at six months, one year, two years and five years after RYGB. The primary endpoint is the incidence of IH.
Conclusion: This study will be the first Danish, randomised, controlled study comparing conventional LRYGB with and without closure of the mesenteric defects. The results will contribute to evidence-based recommendations for the prevention of IH.
Funding: not relevant.
Trial registration: The study was registered with the Danish Data Protection Agency (SN-10-2012) and The Central Denmark Regional Committees on Biomedical Research Ethics (1-01-83-0209-12, SJ-284). The study is registered with clinicaltrials.gov: NCT01595230.
Source: PubMed