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

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

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 Overview

• Status: Terminated
• Conditions: Colonic Polyps; Colonic Neoplasms
• Intervention / Treatment: Device: warmed carbon dioxide insufflation; Device: room temperature air insufflation

Detailed Description

study terminated

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L5G2
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Polyp Detection Rate	time of endoscopy

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Lawrence Hookey, MD, Queens University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Colonoscopy; Colonic Polyps; Carbon Dioxide; Insufflation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Intestinal Polyps; Polyps; Colonic Polyps; Colonic Neoplasms
• Other Study ID Numbers: 6011440; DMED-1658-13 (Other Identifier: Queen's University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO