Underwater Endoscopic Mucosal Resection Versus Hot Snare Polypectomy in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size: A Single-center, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Post-polypectomy Bleeding
研究概览
简要总结
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (UEMR) and hot snare polypectomy (HSP) in treating Pedunculated colorectal polyps less than 10mm in size.
详细描述
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients with pedunculated colorectal polyps less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Hot snare polypectomy (HSP).
- Collecting variables which consist of primary and secodary outcomes.
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
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 35 and 80 years
- •Pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy
- •0-Isp or 0-Ip according to Paris classification
- •Patients must sign an informed consent form prior to registration in study
排除标准
- •Unsuitable for removal by UEMR or HSP
- •Suspected malignancy
- •History of inflammatory bowel disease or colorectal resection
- •Familial adenomatous polyposis or Lynch syndrome
- •Patients taking anticoagulant and antiplatelet agents before the examination
- •Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale score < 6
- •Pregnancy or breastfeeding
- •Severe comorbid disease involving the heart, lungs, liver, or kidneys.
- •Concurrent serious conditions, including other active malignancies or severe infectious diseases
研究组 & 干预措施
UEMR in treating Pedunculated colorectal polyps less than 10mm in size
The UEMR procedure included the following: (1) Water infusion to distend the intestinal lumen; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery
干预措施: underwater endoscopic mucosal resection (Procedure)
HSP in treating Pedunculated colorectal polyps less than 10mm in size
The HSP procedure included the following: (1) entrapment and resection of the polyp with a snare with electrocautery.
干预措施: Hot snare polypectomy (Procedure)
结局指标
主要结局
Post-polypectomy Bleeding
时间窗: 2 weeks after the procedure
Presence of Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） or Clinically Significant Delayed Post-polypectomy Bleeding (CSDPB). CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis. CSDPB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
次要结局
- Delayed perforation(2 weeks after the procedure)
- en bloc resection(immediately after the procedure)
- R0 resection(2 weeks after the procedure)
- postoperative electrocoagulation syndrome(2 weeks after the procedure)