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

Trials. 2024 Jan 2;25(1):7. doi: 10.1186/s13063-023-07841-9.

Abstract

Background: Petersen's hernia, which occurs after Billroth-II (B-II) or Roux-en-Y (REY) anastomosis, can be reduced by defect closure. This study aims to compare the incidence of bowel obstruction above Clavien-Dindo classification grade III due to Petersen's hernia between the mesenteric fixation method and the conventional methods after laparoscopic or robotic gastrectomy.

Methods: This study was designed as prospective, single-blind, non-inferiority randomized controlled multicenter trial in Korea. Patients with histologically diagnosed gastric cancer of clinical stages I, II, or III who underwent B-II or REY anastomosis after laparoscopic or robotic gastrectomy are enrolled in this study. Participants who meet the inclusion criteria are randomly assigned to two groups: a CLOSURE group that underwent conventional Petersen's defect closure method and a MEFIX group that underwent the mesenteric fixation method. The primary endpoint is the number of patients who underwent surgery for bowel obstruction caused by Petersen's hernia within 3 years after laparoscopic or robotic gastrectomy.

Discussion: This trial is expected to provide high-level evidence showing that the MEFIX method can quickly and easily close Petersen's defect without increased postoperative complications compared to the conventional method.

Trial registration: ClinicalTrials.gov NCT05105360. Registered on November 3, 2021.

Keywords: Gastrectomy; Gastric neoplasm; Internal hernia; Minimally invasive surgery.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Gastric Bypass* / adverse effects
  • Hernia, Abdominal* / diagnostic imaging
  • Hernia, Abdominal* / etiology
  • Hernia, Abdominal* / prevention & control
  • Humans
  • Laparoscopy* / adverse effects
  • Laparoscopy* / methods
  • Mesentery / surgery
  • Multicenter Studies as Topic
  • Obesity, Morbid* / surgery
  • Postoperative Complications / etiology
  • Postoperative Complications / prevention & control
  • Postoperative Complications / surgery
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Retrospective Studies
  • Single-Blind Method

Associated data

  • ClinicalTrials.gov/NCT05105360

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