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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

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Author(s)
Jae Kyun ParkDae Hwan KimTae-Yong JeonSang-Ho JeongTae Han KimJae-Seok MinRock Bum KimYoung Joon LeeJi Ho ParkYoung Gil SonKi Young YoonKyung Won SeoKi Hyun KimYoonhong KimHyun Dong ChaeSun Hwi HwangSi-Hak LeeJae Hun ChungHyoung-Il KimDong Jin ParkKwang Hee KimSang Hyuk SeoSung Jin OhWoo Yong LeeChang In Choi
Keimyung Author(s)
Son, Young Gil
Department
Dept. of Surgery (외과학)
Journal Title
Trials
Issued Date
2024
Volume
25
Issue
1
Keyword
GastrectomyGastric neoplasmInternal herniaMinimally invasive surgery
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.
Keimyung Author(s)(Kor)
손영길
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1745-6215
Source
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07841-9
DOI
10.1186/s13063-023-07841-9
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45590
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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