Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 429
- 主要终点
- Complete resection rate
研究概览
简要总结
This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.
It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.
详细描述
In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).
In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.
The study is designed as a non-inferiority trial.
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
- None
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
- •Outpatient colonoscopy
- •Signed, written informed consent
- •At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy
排除标准
- •Implanted cardiac electro converter
- •Severe comorbidity (NYHA 3-4)
- •Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
- •Platelet count < 100
- •Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
- •Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial
结局指标
主要结局
Complete resection rate
时间窗: Hopefully within 4 weeks, when the histopathologist has examined the biopsies
We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.
次要结局
- Factors explaining the primary outcome(During the hospital stay and up to 4 weeks)
- Complications(4 weeks)