Clinical trial NCT02065037: The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection
Official title: The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonic Polyps
Colonic Neoplasms
Keywords: Insufflation
Carbon Dioxide
Colonic Polyps
Colonoscopy
Randomized Controlled Trial
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 229
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Polyp Detection Rate
timeFrame: time of endoscopy
Secondary outcomes:
measure: adenoma detection rate
timeFrame: 2 weeks
measure: advanced lesion per patient detection rate
timeFrame: 2 weeks
Other outcomes:
measure: cecal intubation rate
timeFrame: day of colonoscopy
measure: withdrawal time
timeFrame: day of colonoscopy
measure: anesthetic doses
timeFrame: day of colonoscopy
measure: quality of bowel preparation
timeFrame: day of colonoscopy
measure: patient comfort by a validated nurse administered comfort score
timeFrame: day of colonoscopy
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queens University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References: