Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and 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
- 198
- 试验地点
- 1
- 主要终点
- complete polyp resection rate
研究概览
简要总结
Background:The optimal technique for removal of diminutive or small colorectal polyps is debatable.
Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).
Design：Prospective randomized controlled study. Setting：Three tertiary referral hospitals. Patients：we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a computer-generated random sequence. If a patient had one or more polyps, all eligible polyps were removed using the initially assigned polypectomy protocol. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.
Main Outcome Measurements:The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).
详细描述
1、study objective and Contents
Study objective:
Compare cold snare polypectomy with cold forceps polypectomy with respect to their efficacy and safety for endoscopic resection of small colorectal polyps: a randomized controlled trial.
Study content:
- Main Outcome Measurements: The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).
- Collect the pre-operation and post-operation data of patients who underwent a colonoscopy in the digestive disease center of Wulumuqi General Hospital of Lanzhou Militery Cammand from December 2015. to December 2016.Collect patients clinical data,Laboratory examination data, baseline data.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥20 years who undergo a screening, surveillance, or diagnostic colonoscopy and are subsequently found to have colorectal polyps measuring 3-9 mm in size
- •Patients who signed an informed consent
排除标准
- •patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
- •known coagulopathy
- •history of inflammatory bowel diseases
- •polyposis syndrom
- •Type IV shantian colorectal polyps
- •American Society of Anesthesiology class III or more
- •pregnancy
- •Unable to provide informed consent.
结局指标
主要结局
complete polyp resection rate
时间窗: one year
The primary study outcome was to compare the complete polyp resection rate between groups.Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site.
次要结局
- rate of postpolypectomy adverse events(one year)
研究者
Zhanguo Nie，Professor
Professor of The Fourth Military Medical University
Wulumuqi General Hospital of Lanzhou Military Command