Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part B)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Incidence of Barrett oesophagus after bariatric surgery
研究概览
简要总结
The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.
详细描述
Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: the prevalence and causes of post-operative swallowing disorders and reflux disease are uncertain. Recently, independent study groups described a high incidence of Barrett oesophagus post LSG. Additional research is urgently needed.
The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.
排除标准
- •Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy as a secondary bariatric procedure (e.g. after gastric banding),
- •Patients who received a secondary bariatric operation after laparoscopic gastric bypass or laparoscopic sleeve gastrectomy( e.g. biliopancreatic diversion)
结局指标
主要结局
Incidence of Barrett oesophagus after bariatric surgery
时间窗: 5-7 years after bariatric surgery
incidence of Barrett oesophagus will be compared to will be compared to reference for this age
次要结局
- Prevalence of oesophageal motility disorders after bariatric surgery(5-7 years after bariatric surgery)
- Prevalence of dysphagia after bariatric surgery(5-7 years after bariatric surgery)