• Danish medical journal · Jun 2014

    Randomized Controlled Trial

    Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia.

    • Sara Danshøj Kristensen, Lars Naver, Per Jess, and Andrea Karen Floyd.
    • Kirurgisk Afdeling, Køge Sygehus, Lykkebækvej 1, 4600 Køge, Denmark. sark@regionsjaelland.dk.
    • Dan Med J. 2014 Jun 1; 61 (6): A4854.

    IntroductionThe 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 MethodsThe 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.ConclusionThis 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.Fundingnot relevant.Trial RegistrationThe 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.

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