The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection

Study Overview
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Brief Summary
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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.

Detailed Description
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study terminated

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

Conditions
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Colonic Polyps, Colonic Neoplasms

Intervention / Treatment
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* Device: room temperature air insufflation
* Device: warmed carbon dioxide insufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warmed Carbon Dioxide Insufflation<br>warmed carbon dioxide insufflation used in colonoscopy | Device: warmed carbon dioxide insufflation<br>* comparator arm<br>|
| Active Comparator: Room Temperature Air Insufflation<br>room temperature air insufflation used in colonoscopy | Device: room temperature air insufflation<br>* control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp Detection Rate |  | time of endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate |  | 2 weeks | 
| advanced lesion per patient detection rate |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon Dioxide, Colonic Polyps, Colonoscopy, Randomized Controlled Trial, Insufflation