Comparison between the mesenteric fixation method(MEFIX) and conventional methods at preventing the occurrence of Petersen’s hernia: A study protocol for a multicenter randomized controlled trial

Abstract

Abstract Background Petersen's hernia, which occurs after minimally invasive surgery for gastric cancer, can be reduced by defect closure. This study aimed to demonstrate the incidence of bowel obstruction above Clavien–Dindo classification grade III due to Petersen's hernia between the mesenteric fixation method(MEFIX) and the conventional methods during the 5-year follow-up period after laparoscopic gastric cancer surgery. Methods This prospective, single-blind, non-inferiority randomized controlled trial and multicenter study was conducted at hospitals in Korea. Patients with histologically diagnosed gastric cancer of clinical stage I, II, or III who underwent Roux-en-Y or B- II gastrojejunostomy anastomosis after laparoscopic gastrectomy were enrolled in this study. Patients who met the inclusion criteria were randomly assigned to two groups: a CLOSURE group that underwent Petersen's defect closure method and a MEFIX group that underwent the mesenteric fixation method. Discussion This trial is expected to provide high-level evidence showing that the MEFIX method can quickly and easily close Petersen's defect and reduce postoperative complications compared to the conventional method. It is also expected to be applicable not only after gastric cancer surgery but also after bariatric surgery. Trial registration The MEFIX study protocol was registered in htrp://register.clinicaltrials.gov as NCT05105360 (registration date: November 3, 2021)