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临床试验/NCT02065037
NCT02065037终止不适用

The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial

Queen's University2 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
229
试验地点
2
主要终点
Polyp Detection Rate

研究概览

简要总结

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.

详细描述

study terminated

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital

排除标准

  • 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

结局指标

主要结局

Polyp Detection Rate

时间窗: time of endoscopy

次要结局

  • advanced lesion per patient detection rate(2 weeks)
  • adenoma detection rate(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Lawrence Hookey

Assistant Professor and Director of Endoscopy

Queen's University

研究点 (2)

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