Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
研究概览
简要总结
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
- •FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
- •Consent of participation signed,
- •Affiliation to a social security scheme, or beneficiary of such a scheme.
排除标准
- •Non-optimal preparation (boston score <7 or segment <2),
- •Adenomatous polyposis, familial or assimilated (juvenile, etc.),
- •Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
- •Patient in emergency or deprived of liberty or placed under the authority of a tutor,
- •Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
结局指标
主要结局
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
时间窗: Colonoscopy time
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
次要结局
- Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)(Colonoscopy time)
- Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female(Colonoscopy time)
- Rate of complications(Colonoscopy time and 1 month after)
- Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup(Colonoscopy time)
- Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup(Colonoscopy time)
- G-EYE assistance for endoscope stabilization(Colonoscopy time)