title: Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia.
abstract: BACKGROUND
  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).
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  not relevant.
  
  
  BACKGROUND
  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.
authors.affiliation: Kirurgisk Afdeling, Køge Sygehus, Lykkebækvej 1, 4600 Køge, Denmark. sark@regionsjaelland.dk.
authors.forename: Sara Danshøj
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Lars
authors.initials: L
authors.lastname: Naver
authors.forename: Per
authors.initials: P
authors.lastname: Jess
authors.forename: Andrea Karen
authors.initials: AK
authors.lastname: Floyd
mesh_terms: D018784:Abdominal Abscess / Q000209:etiology; D057868:Anastomotic Leak / Q000209:etiology; D015390:Gastric Bypass / Q000009:adverse effects / Q000379:methods*; D006470:Hemorrhage / Q000209:etiology; D006547:Hernia / Q000517:prevention & control*; D006801:Humans; D045823:Ileus / Q000209:etiology; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008643:Mesentery / Q000601:surgery*; D061646:Operative Time; D010149:Postoperative Pain / Q000209:etiology; D011183:Postoperative Complications / Q000517:prevention & control*; D012107:Research Design; D016037:Single-Blind Method; D013525:Surgical Instruments / Q000706:statistics & numerical data; D058106:Wound Closure Techniques / Q000009:adverse effects