NCT03758872已完成不适用
USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE
Clinique du Trocadéro1 个研究点 分布在 1 个国家目标入组 1,034 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,034
- 试验地点
- 1
- 主要终点
- detection of polyp or adenoma with cuff
研究概览
简要总结
The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.
This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient scheduled for total colonoscopic exploration, during the period study
- •Patient over or equal to 18 years
- •ASA 1, ASA 2, ASA 3
- •No participation in another clinical study
- •Certificate of non opposition signed
排除标准
- •Patient under 18 years old
- •ASA 4, ASA 5
- •Pregnant woman
- •Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, -Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- •Inflammatory bowel disease
- •Known colonic stenosis
- •Diverticulitis less than 6 weeks old
- •Patient unable to give consent or protected by law
- •Opposition expressed for inclusion in the study
结局指标
主要结局
detection of polyp or adenoma with cuff
时间窗: during procedure
次要结局
- POLYP DETECTION RATE(during procedure)
- morbidity : perforation rate(21 DAYS AFTER PROCEDURE)
- CAECAL INTUBATION RATE(DURING PROCEDURE)
- TIME TO REACH CAECUM(DURING PROCEDURE)
- WITHDRAWAL TIME(DURING PROCEDURE)
研究者
研究点 (1)
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