Water Infusion and Carbon Dioxide Insufflation Versus Air Insufflation Versus Air Insufflation Techniques in Screening Colonoscopies in the United States: A Comparative Study Evaluating Safety, Efficacy and Adenoma Detection Rate (ADR)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rate, proximal colon and total
研究概览
简要总结
The purpose of this study is to determine which of the methods of colonoscopy viz. water insufflation or air insufflation or carbon dioxide insufflation is better in detecting the adenomas in colon and also which of these methods is best tolerated by patients.
Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods
详细描述
Significance:
ADR is an independent predictor of risk of post screening colonoscopy colon cancer. A simple method solely controlled by the colonoscopist that enhances proximal ADR holds the promise of rectifying some of the unresolved shortcomings of screening colonoscopy in failing to reduce the occurrence of post screening incident cancers in the proximal colon and the associated cancer mortality.
Hypotheses & Specific Aims:
Primary Hypothesis:
In patients undergoing first time screening a higher ADR will be found in the proximal colon in those randomized to the water method compared to those randomized to the air method or CO2 method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled.
排除标准
- •decline to be randomized
- •unable to give consent
- •non-screening (surveillance or diagnostic) colonoscopy
- •current participation in other colonoscopy studies
- •a medical condition that could increase the risk associated with colonoscopy
- •pregnancy
- •those with a known family history of polyposis syndromes or a family history of colon cancer
结局指标
主要结局
Adenoma Detection Rate, proximal colon and total
时间窗: Day 1, At time of colonoscopy
The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods
次要结局
- Pain scores(during and immediately after colonoscopy on day 1)
- Sedation requirements(Collected at Day 1, during the procedure)