The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection
The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial
Colorectal cancer is the second most common cancer in the world and the second leading cause of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a well characterized adenoma to carcinoma progression. The removal of such precursor lesions reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce spasm of the colon have been investigated to increase adenoma detection rates including the use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body temperature is postulated to have spasmolytic effects. Administration of warmed carbon dioxide during colonoscopy may improve polyp detection.
Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be compared to standard room temperature air insufflation to see if there is a greater detection of polyps per patient.
Methods: Patients undergoing colonoscopy for screening and surveillance indications will be included and randomized to receive either room temperature room air or warmed carbon dioxide (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate will be the primary outcome. Secondary outcomes will include adenoma detection rate and advanced lesion detection rates.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ontario
-
Kingston、Ontario、加拿大、K7L5G2
- Hotel Dieu Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital
Exclusion Criteria:
- patients who have undergone colonic resections
- active inflammatory bowel disease
- hereditary polyposis syndromes
- moderate to severe chronic obstructive pulmonary disease
- obstructive sleep apnea requiring continuous positive airway pressure or biphasic positive airway pressure
- neurologic diagnoses affecting ventilation
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Warmed Carbon Dioxide Insufflation
warmed carbon dioxide insufflation used in colonoscopy
|
comparator arm
|
|
有源比较器:Room Temperature Air Insufflation
room temperature air insufflation used in colonoscopy
|
control arm
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Polyp Detection Rate
大体时间:time of endoscopy
|
time of endoscopy
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
adenoma detection rate
大体时间:2 weeks
|
2 weeks
|
|
advanced lesion per patient detection rate
大体时间:2 weeks
|
2 weeks
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
cecal intubation rate
大体时间:day of colonoscopy
|
day of colonoscopy
|
|
withdrawal time
大体时间:day of colonoscopy
|
day of colonoscopy
|
|
anesthetic doses
大体时间:day of colonoscopy
|
day of colonoscopy
|
|
quality of bowel preparation
大体时间:day of colonoscopy
|
day of colonoscopy
|
|
patient comfort by a validated nurse administered comfort score
大体时间:day of colonoscopy
|
day of colonoscopy
|
合作者和调查者
调查人员
- 首席研究员:Lawrence Hookey, MD、Queens University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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