Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,017
- 试验地点
- 1
- 主要终点
- The rate of re-bleeding
研究概览
简要总结
Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
详细描述
This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.
Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years
- •the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
- •head diameter≥ 10 mm
- •HSP indications were met and no contraindications were found
- •patients (or the legal representative/guardian) with informed consent
排除标准
- •ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)
- •coagulation dysfunction (INR ≥ 1.5, PLT < 50×10 ^9 / L)
- •use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
- •there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
- •incomplete closure of clips (complete closure: spacing between adjacent clips < 1cm)
- •APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
- •surgical treatment, vascular intervention, or blood products were used during the operation
- •use other methods to prevent PPB
- •the bleeding site was not confirmed by endoscopy
- •history of intestinal surgery
- •menstruation or pregnancy
- •not following medical advice
- •participated in other clinical trials and signed its informed consent
结局指标
主要结局
The rate of re-bleeding
时间窗: 30 days after HSP
the rate of re-bleeding within 30 days after operation
次要结局
- Location of re-bleeding sites(30 days after HSP)
- Other postoperative complications(30 days after HSP)
- Expenses of prevention(the 1 day of discharge from medical centers)
研究者
ChenMingkai
Professor
Renmin Hospital of Wuhan University