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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02065037
• Other study ID #: 6011440
• Secondary ID: DMED-1658-13
• Status: Terminated
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 14, 2017
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2017
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

study terminated

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 229
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyps
• Polyps

Intervention

Device:
• room temperature air insufflation
control arm
• warmed carbon dioxide insufflation
comparator arm

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cecal intubation rate		day of colonoscopy
Other	withdrawal time		day of colonoscopy
Other	anesthetic doses		day of colonoscopy
Other	quality of bowel preparation		day of colonoscopy
Other	patient comfort by a validated nurse administered comfort score		day of colonoscopy
Primary	Polyp Detection Rate		time of endoscopy
Secondary	adenoma detection rate		2 weeks
Secondary	advanced lesion per patient detection rate		2 weeks