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

Not Applicable

Terminated

• Conditions: Colonic Neoplasms; Colonic Polyps
• Interventions: Device: room temperature air insufflation; Device: warmed carbon dioxide insufflation

• Registration Number: NCT02065037
• Lead Sponsor: Queen's University

Brief Summary

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

study terminated

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 229

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Room Temperature Air Insufflation	room temperature air insufflation	room temperature air insufflation used in colonoscopy
Warmed Carbon Dioxide Insufflation	warmed carbon dioxide insufflation	warmed carbon dioxide insufflation used in colonoscopy

Primary Outcome Measures

Name	Time	Method
Polyp Detection Rate	time of endoscopy

Secondary Outcome Measures

Name	Time	Method
advanced lesion per patient detection rate	2 weeks
adenoma detection rate	2 weeks

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada