Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Total amount of weight loss
研究概览
简要总结
The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.
详细描述
The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy.
However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently.
In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must meet all the inclusion criteria to participate in this study and list each criterion.
- •Age: 21-65 years
- •Patients going for LSG at participating hospitals.
- •Able to provide informed consent
- •Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.
排除标准
- •Patients who were breast feeding or pregnant
- •Severe psychiatric illness
- •Eating disorder
- •Active neoplastic disease
- •End-stage renal disease
- •Patients with bleeding diathesis
- •Patients with pacemakers or implantable cardiac defibrillators
- •Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
- •Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
- •Treatment with anti-platelet agents that could not be temporarily discontinued
研究组 & 干预措施
Intervention
Endoscopic SASI
干预措施: Endoscopic SASI (Procedure)
结局指标
主要结局
Total amount of weight loss
时间窗: 6 months
Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).
次要结局
- HbA1c(6 months)
- GERD symptoms(6 months)
研究者
Chin Hong Lim
Doctor
Singapore Health Services