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

Primary Purpose

Colonic Polyps, Colonic Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
room temperature air insufflation
warmed carbon dioxide insufflation
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyps focused on measuring Insufflation, Carbon Dioxide, Colonic Polyps, Colonoscopy, Randomized Controlled Trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Warmed Carbon Dioxide Insufflation

Room Temperature Air Insufflation

Arm Description

warmed carbon dioxide insufflation used in colonoscopy

room temperature air insufflation used in colonoscopy

Outcomes

Primary Outcome Measures

Polyp Detection Rate

Secondary Outcome Measures

adenoma detection rate
advanced lesion per patient detection rate

Full Information

First Posted
February 10, 2014
Last Updated
February 14, 2017
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02065037
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
CO2 temperature delivered revealed that warmed CO2 was not being delivered.
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Colonic Neoplasms
Keywords
Insufflation, Carbon Dioxide, Colonic Polyps, Colonoscopy, Randomized Controlled Trial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warmed Carbon Dioxide Insufflation
Arm Type
Experimental
Arm Description
warmed carbon dioxide insufflation used in colonoscopy
Arm Title
Room Temperature Air Insufflation
Arm Type
Active Comparator
Arm Description
room temperature air insufflation used in colonoscopy
Intervention Type
Device
Intervention Name(s)
room temperature air insufflation
Intervention Description
control arm
Intervention Type
Device
Intervention Name(s)
warmed carbon dioxide insufflation
Intervention Description
comparator arm
Primary Outcome Measure Information:
Title
Polyp Detection Rate
Time Frame
time of endoscopy
Secondary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
2 weeks
Title
advanced lesion per patient detection rate
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
cecal intubation rate
Time Frame
day of colonoscopy
Title
withdrawal time
Time Frame
day of colonoscopy
Title
anesthetic doses
Time Frame
day of colonoscopy
Title
quality of bowel preparation
Time Frame
day of colonoscopy
Title
patient comfort by a validated nurse administered comfort score
Time Frame
day of colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Hookey, MD
Organizational Affiliation
Queens University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L5G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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