Colonic PolypsNCT02065037
The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection
A study testing room temperature air insufflation and warmed carbon dioxide insufflation in people with Colonic Polyps and Colonic Neoplasms, run by Queen's University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonic Polyps, Colonic Neoplasms
- What is being tested?
- room temperature air insufflation and warmed carbon dioxide insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial
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.
Read the detailed description
study terminated
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Being tested
- room temperature air insufflation, warmed carbon dioxide insufflation
- Keywords
- Insufflation, Carbon Dioxide, Colonic Polyps, Colonoscopy, Randomized Controlled Trial
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
room temperature air insufflationDevice
control arm
warmed carbon dioxide insufflationDevice
comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Warmed Carbon Dioxide Insufflation | Experimental | warmed carbon dioxide insufflation used in colonoscopy Receives: Device: warmed carbon dioxide insufflation |
| Room Temperature Air Insufflation | Active comparator | room temperature air insufflation used in colonoscopy Receives: Device: room temperature air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp Detection Rate
Measured: time of endoscopy
Secondary outcomes (2)
adenoma detection rate
Measured: 2 weeks
advanced lesion per patient detection rate
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: CO2 temperature delivered revealed that warmed CO2 was not being delivered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065037
- Sponsor's protocol ID
- 6011440
- Other IDs
- DMED-1658-13
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2014
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02065037
- Acronym / sponsor ID
- 6011440
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Keywords
- Insufflation, Carbon Dioxide, Colonic Polyps, Colonoscopy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CO2 temperature delivered revealed that warmed CO2 was not being delivered.
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warmed Carbon Dioxide Insufflation | Experimental | Device: warmed carbon dioxide insufflationwarmed carbon dioxide insufflation used in colonoscopy |
| Room Temperature Air Insufflation | Active comparator | Device: room temperature air insufflationroom temperature air insufflation used in colonoscopy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| room temperature air insufflationcontrol arm | Device | Room Temperature Air Insufflation |
| warmed carbon dioxide insufflationcomparator arm | Device | Warmed Carbon Dioxide Insufflation |
Primary outcome
Polyp Detection Rate
Time frame: time of endoscopy
2 secondary outcomes
adenoma detection rate
Time frame: 2 weeks
advanced lesion per patient detection rate
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: CO2 temperature delivered revealed that warmed CO2 was not being delivered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Hookey, MD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing room temperature air insufflation and warmed carbon dioxide insufflation in people with Colonic Polyps and Colonic Neoplasms, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: CO2 temperature delivered revealed that warmed CO2 was not being delivered.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp Detection Rate (time frame: time of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.