Forskning ved Københavns Universitet - Københavns Universitet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Sara Danshøj Kristensen
  • Lars Naver
  • Per Jess
  • Andrea Karen Floyd

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.

OriginalsprogEngelsk
ArtikelnummerA4854
TidsskriftDanish Medical Journal
Vol/bind61
Udgave nummer6
Sider (fra-til)1-5
Antal sider5
ISSN1603-9629
StatusUdgivet - jun. 2014

ID: 120533316