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

This study has been terminated.
(Investigation of the CO2 temperature delivered revealed that warmed CO2 was not being delivered.)
Sponsor:
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
NCT02065037
First received: February 10, 2014
Last updated: March 30, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Colonic Polyps
Colonic Neoplasms
Device: room temperature air insufflation
Device: warmed carbon dioxide insufflation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Polyp Detection Rate [ Time Frame: time of endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adenoma detection rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • advanced lesion per patient detection rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cecal intubation rate [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]
  • withdrawal time [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]
  • anesthetic doses [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]
  • quality of bowel preparation [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]
  • patient comfort by a validated nurse administered comfort score [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 229
Study Start Date: June 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065037

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Lawrence Hookey, MD Queens University
  More Information

Responsible Party: Dr. Lawrence Hookey, Assistant Professor and Director of Endoscopy, Queen's University
ClinicalTrials.gov Identifier: NCT02065037     History of Changes
Other Study ID Numbers: 6011440  DMED-1658-13 
Study First Received: February 10, 2014
Last Updated: March 30, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Insufflation
Carbon Dioxide
Colonic Polyps
Colonoscopy
Randomized Controlled Trial

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Colonic Neoplasms
Pathological Conditions, Anatomical
Intestinal Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 26, 2016