NCT03254498已完成不适用
Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Adenoma miss rate
研究概览
简要总结
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over
- •Referral for surveillance, or diagnostic colonoscopy
- •Ability to give informed consent
排除标准
- •Absolute contraindications to colonoscopy
- •Established or suspicion of large bowel obstruction or pseudo-obstruction
- •Known colon cancer or polyposis syndromes
- •Known colonic strictures
- •Known severe diverticular segment (that is likely to impede colonoscope passage)
- •Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- •Patients lacking capacity to give informed consent
- •Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure
研究组 & 干预措施
Endocuff assisted colonoscopy
Active Comparator
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
干预措施: Endocuff (Device)
Cap assisted colonoscopy
Placebo Comparator
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
干预措施: cap assisted colonoscopy (CAC) (Device)
结局指标
主要结局
Adenoma miss rate
时间窗: 1 day
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
次要结局
- miss rate of advanced polyps(1 day)
- Mean adenoma per procedure(1 day)
- Endocuff or cap exchange(1 day)
- Ceacal intubation and withdrawal time(1 day)
- Comfort score(1 day)
研究者
研究点 (1)
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