Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 733
- 试验地点
- 1
- 主要终点
- adenoma miss rate(AMR)
研究概览
简要总结
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 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
- •Patients who have signed inform consent form.
排除标准
- •Patients who have undergone colonic resection or polypectomy
- •Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- •Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days
- •Patients with inflammatory bowel diseases
- •Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
- •Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- •Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- •Patients with failed cecal intubation
- •Patients with poor BPQ that necessitated a second bowel preparation
- •Patients with therapeutic colonoscopy for existing lesions
- •Patients refusing to participate or to provide informed consent
结局指标
主要结局
adenoma miss rate(AMR)
时间窗: 60 minutes
Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
次要结局
- advanced adenoma miss rate(AAMR)(60 minutes)
- adenoma detection rate(ADR)(60 minutes)
- adenomas per colonoscopy(APC)(60 minutes)
- patient-level AMR(pAMR)(60 minutes)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital