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

NCT ID: NCT02065037

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-09-30

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

Conditions

Colonic Polyps; Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Warmed Carbon Dioxide Insufflation

warmed carbon dioxide insufflation used in colonoscopy

Group Type: EXPERIMENTAL

warmed carbon dioxide insufflation

Intervention Type: DEVICE

comparator arm

Room Temperature Air Insufflation

room temperature air insufflation used in colonoscopy

Group Type: ACTIVE_COMPARATOR

room temperature air insufflation

Intervention Type: DEVICE

control arm

Interventions

room temperature air insufflation

control arm

Intervention Type: DEVICE

warmed carbon dioxide insufflation

comparator arm

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Assistant Professor and Director of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-1658-13

Identifier Type: OTHER

Identifier Source: secondary_id

6011440

Identifier Type: -

Identifier Source: org_study_id