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

期刊论文
出版模式：

开放获取
发表日期：

2024年1月2日

查看全文

Jae Kyun Park,
Dae Hwan Kim,
Tae-Yong Jeon,
Sang-Ho Jeong,
Tae Han Kim,
Jae-Seok Min,
Rock Bum Kim,
Young Joon Lee,
Ji Ho Park,
Young Gil Son,
Ki Young Yoon,
Kyung Won Seo,
Ki Hyun Kim,
Yoonhong Kim,
Hyun Dong Chae,
Sun Hwi Hwang,
Si-Hak Lee,
Jae Hun Chung,
Hyoung-Il Kim,
Dong Jin Park,
Kwang Hee Kim,
Sang Hyuk Seo,
Sung Jin Oh,
Woo Yong Lee,
Chang In Choi

摘要

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.