Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm) - A Randomised Control Trail.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Assess the complete resection rate
研究概览
简要总结
OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.
DESIGN : A Randomised interventional study. Sample size: 330
详细描述
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This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
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In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
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After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.
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A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patients will be randomised to C-EMR and H-EMR by a computer generated sequence provided in turn by the research assistant. The patient, pathologist and statistician will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult above 18 years
- •polyp size greater than 5-10mm.
排除标准
- •Inflammatory bowel disease
- •Familial Polyposis Syndromes
- •Patient who is unable to understand study protocol or not consenting
- •Severe coagulopathy (INR Greater than 1.5 platelets)
- •Receiving antiplatelets withing 5 days of procedure
- •If antiplatelets stopped for 5 days-they were restarted on next day after procedure.
结局指标
主要结局
Assess the complete resection rate
时间窗: 1 YEAR
Primary outcome will be tested with chi-square test or Fisher's exact test. The level of significance has been set at 5%. To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95% confidence interval.
次要结局
- Secondary outcomes include procedure time, cost and adverse events.(1 YEAR)