Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity

Официальное название

Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial

Обзор

This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.

Подробное описание

Sleeve gastrectomy is an established therapeutic option for morbidly obese patients without preexisting gastroesophageal reflux disease. The novel single anastomosis sleeve ileal bypass (SASI) procedure is already introduced in Norway at a private high-volume bariatric hospital. The purpose of this study is to evaluate the effects of SASI in comparison to an established bariatric procedure, i.e. sleeve gastrectomy. The primary end point is 2-year changes in BMI after sleeve gastrectomy and SASI.

Вмешательства

• Процедура Single anastomosis sleeve ileal bypass
  The abdominal cavity is entered directly (visual trocar) with or without the use of Verres needle. A 6-port set up and a liver retractor is utilized. A sleeve gastrectomy is performed as described below, but division of the stomach starts 6 cm proximal to the pylorus. The small bowel is measured 300cm from the ileocecal valve, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly v
• Процедура Sleeve gastrectomy
  In the laparoscopic sleeve gastrectomy, the abdominal cavity is entered directly with a visual trocar with or without the use of Verres needle. The set up includes a total of 5 ports. The Natanson liver retractor is utilized. The greater omentum is separated from the major side of the stomach from the pylorus to the angle of His. The left crus is visualized and the hiatus is inspected for the presence of hernia. A 36 French bougie is introduced and the stomach is divided along this from 4-5cm pr

Первичные конечные точки

• Changes in body-mass index (BMI) [Срок оценки: 2 year]

Вторичные конечные точки (12)

• Change in prevalence of esophagitis. [Срок оценки: 2 year]
• Change in prevalence of gastroesophageal reflux disease. [Срок оценки: 2 year]
• Complications [Срок оценки: 6 weeks (100 days for deaths), 2 year, 5 year]
• Obesity-related comorbid conditions. [Срок оценки: 2 year, 5 year]
• Vitamin concentrations [Срок оценки: 2 year, 5 year]
• Health-related quality of life [Срок оценки: 2 year, 5 year]
• Obesity-related symptoms [Срок оценки: 2 year, 5 year]
• Gastrointestinal symptoms [Срок оценки: 2 year, 5 year]
• Gastroesophageal reflux disease symptoms [Срок оценки: 2 year, 5 year]
• Bowel habits [Срок оценки: 2 year, 5 year]
• Revisional surgery [Срок оценки: 2 year, 5 year]
• Long-term changes in BMI [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Morbid obesity at referral for bariatric surgery (i.e. a body-mass index \[BMI\] of ≥35 kg/m2 with obesity-related comorbid conditions or ≥40 kg/m2 with or without such comorbidities).
• Age 20-60 years.
• Previous failed attempts of weight loss.
• Norwegian speaking patients.

Критерии исключения

• BMI ≥55 kg/m2.
• A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).
• Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.
• Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma.
• Achalasia
• Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Норвегия · 2 центра

• The Morbid Obesity Center, Vestfold Hospital Trust — Tønsberg
• Oslo University Hospital — Oslo

Идентификаторы

NCT: NCT05611697 · 319260

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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