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| ID | Type | Description | Link |
|---|---|---|---|
| DMED-1658-13 | Other Identifier | Queen's University |
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CO2 temperature delivered revealed that warmed CO2 was not being delivered.
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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.
study terminated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warmed Carbon Dioxide Insufflation | Experimental | warmed carbon dioxide insufflation used in colonoscopy |
|
| Room Temperature Air Insufflation | Active Comparator | room temperature air insufflation used in colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| room temperature air insufflation | Device | control arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection Rate | time of endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma detection rate | 2 weeks | |
| advanced lesion per patient detection rate | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| cecal intubation rate | day of colonoscopy | |
| withdrawal time | day of colonoscopy | |
| anesthetic doses |
Inclusion Criteria:
-outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Hookey, MD | Queens University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Kingston | Ontario | K7L5G2 | Canada |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| warmed carbon dioxide insufflation |
| Device |
comparator arm |
|
| day of colonoscopy |
| quality of bowel preparation | day of colonoscopy |
| patient comfort by a validated nurse administered comfort score | day of colonoscopy |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |