Water Immersion and Polyp Detection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Adenoma Miss Rate
研究概览
简要总结
We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- 是
入选标准
- •all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University
排除标准
- •includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
研究组 & 干预措施
Water Infusion first
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
干预措施: Water Infusion first (Procedure)
CO2 Insufflation First
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
干预措施: CO2 Insufflation First (Procedure)
结局指标
主要结局
Adenoma Miss Rate
时间窗: Through procedure, an average of 1 hr
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations
次要结局
- Patient-level Miss Rate(1 hour or the duration of the procedure)
- Adenoma < 6mm Detection Rate(1 hour or the duration of the procedure)
研究者
Joseph Anderson
Associate Professor
White River Junction Veterans Affairs Medical Center