Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,059
- 试验地点
- 2
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. 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 as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)
详细描述
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. 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 as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
Number of patients:
2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).
Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).
Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 100 Years（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
Adenoma detection rate (ADR)
时间窗: during procedure
rate (%) of colonoscopies with one or more adenoma detected
次要结局
- Polyp detection rate (PDR)(during procedure)
- Serrated polyp detection rate (SPDR)(during procedure)
- Advanced neoplasia detection rate (ANDR)(during procedure)
- Time to reach caecum (sec)(during procedure)
- Morbidity: perforation rate (%)(21 days after procedure)
- Morbidity: bleeding rate (%)(21 days after procedure)
- caecal intubation rate (%)(during procedure)
- withdrawal time (sec)(during procedure)
研究者
KARSENTI
MD, Principal Investigator
Société Française d'Endoscopie Digestive