Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 710
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.
详细描述
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy.
This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients.
This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine 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
- Double (Participant, Outcomes Assessor)
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
- •All patients who are attending for screening, surveillance or diagnostic colonoscopy.
排除标准
- •patients with absolute contraindications to colonoscopy;
- •patients with established or suspicion of large bowel obstruction or pseudo-obstruction;
- •patients with known colonic strictures;
- •patients with a known severe diverticular segment (that is likely to impede colonoscope passage);
- •patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis);
- •patients lacking capacity to give informed consent;
- •patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure;
- •patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy;
- •examination performed by a non-expert colonoscopist;
- •pregnancy.
研究组 & 干预措施
Endocuff colonoscopy
Endocuff-assisted colonoscopy
干预措施: Endocuff (Device)
Cap colonoscopy
Cap-assisted colonoscopy
干预措施: cap (Device)
结局指标
主要结局
Adenoma detection rate
时间窗: 7 days
number of patients with at least one adenoma/total number of patients
次要结局
- mean adenoma per patient(7 days)
研究者
JAVIER SOLA VERA SANCHEZ
M.D, Ph D
Hospital General Universitario Elche