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

Sponsor

Queen's University (Other)

Overall Status

Terminated

CT.gov ID

NCT02065037

Collaborator

(none)

229

Enrollment

Location

Arms

Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps Colonic Neoplasms	Device: room temperature air insufflation Device: warmed carbon dioxide insufflation	N/A

Detailed Description

study terminated

Study Design

Study Type:

Interventional

Actual Enrollment :

229 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warmed Carbon Dioxide Insufflation warmed carbon dioxide insufflation used in colonoscopy	Device: warmed carbon dioxide insufflation comparator arm
Active Comparator: Room Temperature Air Insufflation room temperature air insufflation used in colonoscopy	Device: room temperature air insufflation control arm

Arm

Intervention/Treatment

Experimental: Warmed Carbon Dioxide Insufflation

warmed carbon dioxide insufflation used in colonoscopy

Device: warmed carbon dioxide insufflation

comparator arm

Active Comparator: Room Temperature Air Insufflation

room temperature air insufflation used in colonoscopy

Device: room temperature air insufflation

control arm

Outcome Measures

Primary Outcome Measures

Polyp Detection Rate [time of endoscopy]

Secondary Outcome Measures

adenoma detection rate [2 weeks]
advanced lesion per patient detection rate [2 weeks]

Other Outcome Measures

cecal intubation rate [day of colonoscopy]
withdrawal time [day of colonoscopy]
anesthetic doses [day of colonoscopy]
quality of bowel preparation [day of colonoscopy]
patient comfort by a validated nurse administered comfort score [day of colonoscopy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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