Polypectomy With Hot vs Cold Snare in Small Colonic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of participants with presence of adenomatous tissue al the base of polypectomy
研究概览
简要总结
Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.
详细描述
- Introduction
Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. It is estimated that in 2008, 1233,000 new cases were diagnosed and more than 600,000 people died for this reason throughout the world. Colonoscopy is the technique of choice for both diagnosis and prevention, since the identification and removal of colonic adenomas reduces the incidence of CRC by up to 76%.
Different endoscopic techniques have been developed for the removal of adenomas; The choice of some over others is made according to the size, morphology and location of the lesion. 2. Hypothesis
Conceptual hypothesis:
Cold snare polypectomy presents a proportion of incomplete polypectomies similar to polypectomy with hot snare.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years scheduled to undergo a colonoscopy.
排除标准
- •Absence of lesions of 5-9 mm.
- •Contraindication for polypectomy (anticoagulant treatment, treatment with clopidogrel, coagulopathy or severe thrombocytopenia)
- •Loss of polypectomy specimen
- •Refusal to participate
结局指标
主要结局
Number of participants with presence of adenomatous tissue al the base of polypectomy
时间窗: 3 months
Number of patients with polypoid tissue at the base of polypectomy
次要结局
- Number of participants with Postpolypectomy Complications(21-28 days)
研究者
Marina de Benito Sanz
Principal investigator
Hospital del Río Hortega
