The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial.

IF 2.9 3区医学 Q1 SURGERY

Obesity Surgery Pub Date : 2025-03-14 DOI:10.1007/s11695-025-07751-6

Maureen Tissink, Tim Verhagen, Ian Faneyte, Eric Hazebroek, Sake Oost, Josien Timmerman, Anouk Veldhuis, Marc van Det

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引用次数: 0

Abstract

Background: Long-term recurrent weight gain remains a persistent challenge in metabolic bariatric surgery (MBS). One strategy for managing recurrent weight gain involves the placement of a non-adjustable silicone ring around the reduced stomach pouch. This technique may lead to more significant weight loss and a reduced risk of long-term recurrent weight gain. Although several studies have demonstrated the effectiveness of silicone rings in combination with Roux-en-Y gastric bypass (RYGB), randomized studies providing long-term data on the effectiveness of primary banded one-anastomosis gastric bypass (OAGB) are lacking.

Methods: A total of 210 patients will be included in this prospective, non-blinded, single-center randomized controlled trial. The primary endpoint is the difference in total weight loss percentage (%TWL) 5 years post-surgery. Secondary outcomes include excess weight loss percentage (%EWL), changes in obesity complications, quality of life, and adverse events related to the surgical procedures. The study population will consist of patients eligible for primary OAGB aged 18 years and older.

Conclusions: The RiMini trial aims to investigate whether there is a significant difference in long-term weight reduction expressed as %TWL in patients undergoing an OAGB with or without the addition of a silicone ring 5 years after surgery.

Trial registration: This study is registered at Clinicaltrials.gov (NCT05472922) on the 25th of July, 2022.

查看原文本刊更多论文

带状单吻合术胃旁路试验（RiMini试验）：前瞻性单中心随机对照试验方案。

背景：长期复发性体重增加仍然是代谢减肥手术（MBS）的一个持续挑战。治疗复发性体重增加的一个策略是在缩小的胃袋周围放置一个不可调节的硅胶环。这项技术可能会导致更显著的体重减轻，并降低长期复发性体重增加的风险。虽然有几项研究证明了硅胶环与Roux-en-Y胃旁路术（RYGB）联合使用的有效性，但缺乏提供原发性带状单吻合术胃旁路术（OAGB）有效性长期数据的随机研究。方法：210例患者将被纳入这项前瞻性、非盲、单中心随机对照试验。主要终点是术后5年总体重减轻百分比（%TWL）的差异。次要结局包括超重减重百分比（%EWL）、肥胖并发症的改变、生活质量和与手术相关的不良事件。研究人群将包括18岁及以上的原发性OAGB患者。结论：RiMini试验旨在调查术后5年接受OAGB的患者在有或没有添加硅胶环的情况下，长期体重减轻是否有显著差异，以%TWL表示。试验注册：本研究于2022年7月25日在Clinicaltrials.gov （NCT05472922）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Obesity Surgery 医学-外科

CiteScore

5.80

自引率

24.10%

发文量

567

审稿时长

3-6 weeks

期刊介绍： Obesity Surgery is the official journal of the International Federation for the Surgery of Obesity and metabolic disorders (IFSO). A journal for bariatric/metabolic surgeons, Obesity Surgery provides an international, interdisciplinary forum for communicating the latest research, surgical and laparoscopic techniques, for treatment of massive obesity and metabolic disorders. Topics covered include original research, clinical reports, current status, guidelines, historical notes, invited commentaries, letters to the editor, medicolegal issues, meeting abstracts, modern surgery/technical innovations, new concepts, reviews, scholarly presentations and opinions. Obesity Surgery benefits surgeons performing obesity/metabolic surgery, general surgeons and surgical residents, endoscopists, anesthetists, support staff, nurses, dietitians, psychiatrists, psychologists, plastic surgeons, internists including endocrinologists and diabetologists, nutritional scientists, and those dealing with eating disorders.