Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Presence of delayed bleeding
研究概览
简要总结
The hypothesis of this study is that prophylactic coagulation therapy with coagulation forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection (EMR) will reduce the rate of delayed bleeding when compared with current established standard EMR technique.
详细描述
Delayed bleeding from the site of the resection remains one of the most common complications following EMR, occurring in up to 12% of patients. The purpose of the study is to prevent such bleeding with the use of a technique known as: "coagulation therapy." This therapy involves using a small dose of heat energy that results in clotting(coagulation) of a blood vessel. It is already used widely in the stomach and we intend using this on a lower setting to blood vessels that are exposed after the resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients referred to Westmead Hospital Endoscopy unit for endoscopic removal of a large sessile colonic polyp sized >20mm
- •Age >18 years
- •Able to give informed consent to involvement in trial
排除标准
- •Pregnancy: currently pregnant or attempting to become pregnant
- •Lactation: currently breastfeeding
- •Taken clopidogrel within 7 days
- •Taken warfarin within 5 days
- •Had full therapeutic dose unfractionated heparin within 6 hours
- •Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- •Known clotting disorder
结局指标
主要结局
Presence of delayed bleeding
时间窗: 14 days
次要结局
未报告次要终点
研究者
Professor Michael Bourke
Dr Michael Bourke
Western Sydney Local Health District