Obesity surgery · 2025
The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Tissink Maureen, Verhagen Tim, Faneyte Ian, Hazebroek Eric, Oost Sake, Timmerman Josien, Veldhuis Anouk, van Det Marc
Аннотация
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.
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.