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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초록

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. © 2023, The Author(s).

키워드

GastrectomyGastric neoplasmInternal herniaMinimally invasive surgeryEN-Y RECONSTRUCTIONGASTRIC BYPASSINTERNAL HERNIA
제목
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
저자
Park, Jae KyunKim, Dae HwanJeon, Tae-YongJeong, Sang-HoKim, Tae HanMin, Jae-SeokKim, Rock BumLee, Young JoonPark, Ji HoSon, Young GilYoon, Ki YoungSeo, Kyung WonKim, Ki HyunKim, YoonhongChae, Hyun DongHwang, Sun HwiLee, Si-HakChung, Jae HunKim, Hyoung-IlPark, Dong JinKim, Kwang HeeSeo, Sang HyukOh, Sung JinLee, Woo YongIn Choi, Chang
DOI
10.1186/s13063-023-07841-9
발행일
2024-01
유형
Article
저널명
Trials
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