Kristensen Sara Danshøj, Naver Lars, Jess Per, Floyd Andrea Karen
Kirurgisk Afdeling, Køge Sygehus, Lykkebækvej 1, 4600 Køge, Denmark.
Dan Med J. 2014 Jun;61(6):A4854.
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).
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.
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.
not relevant.
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.
本研究旨在评估在胃旁路手术中闭合肠系膜缺损以避免内疝（IH）的利弊。
本研究为单中心、随机、对照、双盲试验。患者被随机分为两组，一组接受不闭合肠系膜缺损的传统腹腔镜Roux-en-Y胃旁路手术（LRYGB，n = 250），另一组接受使用疝夹闭合缺损的RYGB手术（n = 250）。在RYGB术后6个月、1年、2年和5年进行随访。主要终点是内疝的发生率。
本研究将是丹麦第一项比较闭合与不闭合肠系膜缺损的传统LRYGB手术的随机对照研究。研究结果将为预防内疝的循证推荐提供依据。
无关。
本研究已在丹麦数据保护局（编号：SN-10-2012）和丹麦中北部地区生物医学研究伦理委员会（编号：1-01-83-0209-12，SJ-284）注册。本研究已在clinicaltrials.gov注册，注册号为：NCT01595230。
