Endoscopic Sleeve Gastroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
详细描述
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years old and < 60 years old
- •Patient with morbid obesity for at least 2 years
- •Patient who failed medical and diet treatment of obesity
- •Patient with no contraindication to anesthesia
- •Patient able to understand the study and to provide informed consent.
排除标准
- •Patient with inflammatory, tumoral or bad quality tissues at endoscopy
- •Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
- •Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
- •Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
- •Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
- •Patient with a severe coagulopathy (prothrombin time > 3 seconds or thrombocytic count < 50 000/mm3) or treated with heparin, coumadin, warfarin or any other anticoagulants and drugs preventing coagulation or platelet aggregation, except aspirin and nonsteroidal anti-inflammatory drugs
- •Pregnancy, breastfeeding or woman without contraception
- •Patient with a congestive heart failure, arrhythmia or unstable coronary heart disease
- •Patient using or having used diet drugs within the last 30 days or intending to use them during study follow-up
- •Patient under drug treatment within the last 3 months known to induce weight gain
- •Patient with eating disorders or uncontrolled, poorly controlled or suspected psychiatric disease
- •Patient in a poor condition according to investigator
- •Patient in exclusion period (determined by a previous study or in progress)
- •Patient with significative weight loss between date of enrollment in the study and date of procedure
- •Patient with a systemic infection the day of procedure.
结局指标
主要结局
Weight loss
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Body mass index variation
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Excess weight loss
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
次要结局
- Procedure reproducibility(7 days, 1 - 3 - 6 - 9 and 12 months after procedure)
- Comorbidities improvement(7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure)
- Quality of life improvement(3 - 12 - 18 and 24 months after procedure)
- Modification in the feeling of satiety(1 - 3 - 6 - 12 - 18 and 24 months after procedure)