Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,027
- 试验地点
- 1
- 主要终点
- adenoma detection rate(ADR)
研究概览
简要总结
A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in 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
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age is between 40-
- •Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- •Patients who have signed inform consent form
排除标准
- •Patients who have undergone colonic resection
- •Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- •Patients with severe chronic cardiopulmonary and renal disease.
- •Patients who are unwilling or unable to consent.
- •Patients who are not suitable for colonoscopy
- •Patients who received urgent or therapeutic colonoscopy
- •Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
- •Patients who are taking aspirin, clopidogrel or other anticoagulants
- •Patients with Aronchick score > 3
结局指标
主要结局
adenoma detection rate(ADR)
时间窗: 30mins
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
次要结局
- adenomas per colonoscopy(APC)(30mins)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital