Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The efficacity of closure of fistulas by clips ovesco
研究概览
简要总结
Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age upper to 18 years
- •surgery bariatrique typical Sleeve
- •presence of one or two fistulas < 1 cm, beforehand drained and without sepsis evolutionary
- •signature of the consent
排除标准
- •surgery bariatrique other one than Sleeve
- •refusal of the patient of this endoscopic repeated coverage(care) requiring several sessions of endoscopies under AG with hospitalizations
- •Current Sepsis
- •not drained cavity
- •Absence of signed consent
研究组 & 干预措施
clips OST
干预措施: CLIP OST (Device)
结局指标
主要结局
The efficacity of closure of fistulas by clips ovesco
时间窗: 12 months
次要结局
- The efficacity of the suture in 3 months of these complex refractory fistulas(12 months)