Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients with closure of staple line leak
研究概览
简要总结
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.
详细描述
Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
- •Age 18 years or older.
- •Written informed consent.
排除标准
- •Declined informed consent.
- •Leaks detected later than 30 days after surgery.
结局指标
主要结局
Number of patients with closure of staple line leak
时间窗: up to 16 weeks
Resolution of the fistula with no further need for intervention (surgical or endoscopic).
次要结局
- Number of endoscopic interventions(up to 16 weeks)
- Hospital stay(up to 24 weeks)
- Mortality(up to 24 weeks)
研究者
Markus Reiser, M.D.
Chief Dept. Gastroenterology
Ruhr University of Bochum