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

Q

Queen's University

Status

Terminated

Conditions

Colonic Polyps
Colonic Neoplasms

Treatments

Device: warmed carbon dioxide insufflation
Device: room temperature air insufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT02065037
6011440
DMED-1658-13 (Other Identifier)

Details and patient eligibility

About

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.

Full description

study terminated

Enrollment

229 patients

Sex

All

Ages

40+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

229 participants in 2 patient groups

Warmed Carbon Dioxide Insufflation
Experimental group
Description:
warmed carbon dioxide insufflation used in colonoscopy
Treatment:
Device: warmed carbon dioxide insufflation
Room Temperature Air Insufflation
Active Comparator group
Description:
room temperature air insufflation used in colonoscopy
Treatment:
Device: room temperature air insufflation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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