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临床试验/NCT02374515
NCT02374515已完成不适用

Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.

University of Naples2 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2015年2月1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
275
试验地点
2
主要终点
adenoma detection rate

研究概览

简要总结

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colonoscopy: Screening , Surveillance, Diagnostic

排除标准

  • Pregnancy
  • age<18 years
  • age > 80 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation

结局指标

主要结局

adenoma detection rate

时间窗: 20 min.

次要结局

未报告次要终点

研究者

发起方
University of Naples
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Domenico De Palma

Full Professor of Surgery

Federico II University

研究点 (2)

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