Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Randomizing for EPGB procedure, Randomizing for OAGB procedure.
- Кому может быть актуально
- Состояния в реестре: Bariatric Surgery Candidate. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial
Обзор
The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
Подробное описание
Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.
The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.
An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.
Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).
Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.
Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
Вмешательства
- Процедура Randomizing for EPGB procedure
Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires. - Процедура Randomizing for OAGB procedure
Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.
Первичные конечные точки
- Weightloss short term [Срок оценки: 1, 3 and 5 years postoperatively]
Вторичные конечные точки (12)
- Weightloss long term [Срок оценки: 5-10 years postoperatively]
- Complications short term [Срок оценки: up to 30 days postoperatively]
- Complications long term [Срок оценки: from 30 days until 10 years postoperatively]
- Revision of the bypass [Срок оценки: until 10 years postoperatively]
- Comorbidities [Срок оценки: until 10 years postoperatively]
- Deficiencies in blood - red blood count [Срок оценки: until 10 years postoperatively]
- Deficiencies in blood - vitamins [Срок оценки: until 10 years postoperatively]
- Deficiencies in blood - electrolytes [Срок оценки: until 10 years postoperatively]
- Reflux/dumping questionnaire [Срок оценки: until 10 years postoperatively]
- Health related quality of life questionnaire [Срок оценки: until 10 years postoperatively]
- Peroperative complications [Срок оценки: until 10 years postoperatively]
- Number of patients with peroperative conversion to sleeve [Срок оценки: until 10 years postoperatively]
Критерии участия
Критерии включения
- BMI≥45
- Bariatric guidelines Fried
- Age 18-65
- Dedication to guided preoperative program
- Intention to follow full postoperative program
Критерии исключения
- Secondary bariatric procedure
- Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing or medication related)
- Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa)
- Renal function disorder (MDRD <30) or liver disease
- Anticipated absence of yearly medical follow up
- Does not speak Dutch language
- Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06204939 · 1