NCT02765022已完成不适用
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.
Fundacion Miguel Servet2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Delayed hemorrhage
研究概览
简要总结
An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •18 years and older
- •Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
- •Medium-high risk of delayed bleeding (DB risk score ≥ 4)
- •Informed consent.
排除标准
- •Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
- •Lesions resected by endoscopic submucosal resection.
- •Incomplete resections.
- •Resections with suspected deep submucosal invasion.
- •Mucosal defects treated with clips for known or suspected damage to the muscle layer.
- •Lesions with low risk of delayed bleeding (DB risk score ≤3).
- •Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
研究组 & 干预措施
No clip
Active Comparator
No clip closure of mucosal defects after endoscopic mucosal resection. Observation.
干预措施: No clip closure (Procedure)
Clip
Experimental
Clip closure of mucosal defects after endoscopic mucosal resection.
干预措施: Clip closure (Device)
结局指标
主要结局
Delayed hemorrhage
时间窗: 15 days post-EMR
次要结局
未报告次要终点
研究者
研究点 (2)
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