跳至主要内容
临床试验/NCT03373136
NCT03373136已完成不适用

Comparison of the Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 4,270 人开始时间: 2018年2月7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
入组人数
4,270
试验地点
1
主要终点
Delayed bleeding rate

研究概览

简要总结

In this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

详细描述

The investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in Taiwan. Subjects who are less than 40 years old and has contraindication will be excluded from this study. All the candidates for enrollment will sign the inform consent at the outpatient clinic. Once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. In the group with cold snaring, polypectomy will be done without electrocautery. In the hot snaring group, the polypectomy will be performed with electrocautery. The bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. The colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

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)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy

排除标准

  • •Subjects who are less than 40 years old and has contraindication will be excluded from this study

研究组 & 干预措施

Cold snaring

Experimental

Polypectomy will be done without electrocautery

干预措施: Polypectomy (Device)

Hot snaring

Active Comparator

Polypectomy will be performed with electrocautery

干预措施: Polypectomy (Device)

结局指标

主要结局

Delayed bleeding rate

时间窗: 2 weeks

Anal bleeding with spontaneously stop; drop of Hb more than 2 gm/dl in comparison with baseline; transfusion needed; hemostasis by : colonoscopy, angiography, surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Compare Bleeding Risk Between Cold and Hot Snaring... | 临床试验