PolypsPhase 4NCT01461564
Carbon Dioxide During Screening Unsedated Colonoscopy
A Phase 4 study testing Colonoscopy in people with Polyps, run by Jagiellonian University at 1 site in Poland.
Trial summary
Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Polyps
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 4
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50 yo and more
- no previous large bowel operations
- no previous colonoscopy
- informed consent
Who cannot join
- previous colonoscopy
- previous large bowel operations/ polypectomies
Trial locations and contacts
1 site in 1 country.
Poland1 site
1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University
Cracow, Malopolska, 31-501
About this study
Official title: Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. One of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of air during colonoscopy.
Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.
Read the detailed description
The study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. The examinations were performed with Olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. The patients were randomly assigned to Group I and II with either air or carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a Visual Analogue Scale.
- Conditions
- Polyps
- Being tested
- Colonoscopy
- Keywords
- screening, colonoscopy, carbon dioxide, air, pain score, complications
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Also called Endoscopy, Flexible endoscopy
Screening colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide | Experimental | Patients insufflated with carbon dioxide during screening colonoscopy Receives: Procedure: Colonoscopy |
| Air | Active comparator | Patients insufflated with air during screening colonoscopy Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of procedure
Time from introduction of a colonoscope to removal of the colonoscope.
Measured: 1 hour
Secondary outcomes (4)
coecal intubation time
Time from introduction of a colonoscope to intubation of the coecumo
Measured: 1 hour
pain immediately after the procedure
Pain assessed by VAS scale immediately after colonoscopy
Measured: 1 min
pain 15 minutes after colonoscopy
Pain assessed by VAS scale 15 minutes after colonoscopy
Measured: 15 min
complication rate
any compication of screening colonoscopy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, Jagiellonian University
- Investigators
- Miroslaw Szura, MD PhD, Study director, I Dept of General, Oncological and GI Surgery Jagiellonian UniversityRadoslaw Pach, MD PhD, Principal investigator, I Dept of General, Oncological and GI Surgery Jagiellonian UniversityAndrzej Matyja, MD PhD, Study chair, I Dept of General, Oncological and GI Surgery Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461564
- Sponsor's protocol ID
- Cracow CO2 Trial
- Status last verified
- Jun 2014
- First submitted
- 26 Oct 2011
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Szura M, Pach R, Matyja A, Kulig J. Carbon dioxide insufflation during screening unsedated colonoscopy: a randomised clinical trial. Eur J Cancer Prev. 2015 Jan;24(1):37-43. doi: 10.1097/CEJ.0000000000000047.
PubMed 24915135
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
- ClinicalTrials.gov ID
- NCT01461564
- Acronym / sponsor ID
- Cracow CO2 Trial
- Conditions
- Polyps
- Keywords
- screening, colonoscopy, carbon dioxide, air, pain score, complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Oct 2011 (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.
Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. One of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of air during colonoscopy.
Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.
Detailed description
The study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. The examinations were performed with Olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. The patients were randomly assigned to Group I and II with either air or carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a Visual Analogue Scale.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide | Experimental | Procedure: ColonoscopyPatients insufflated with carbon dioxide during screening colonoscopy |
| Air | Active comparator | Procedure: ColonoscopyPatients insufflated with air during screening colonoscopy |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 50 yo and more
- no previous large bowel operations
- no previous colonoscopy
- informed consent
Key exclusion criteria (2 listed)
- previous colonoscopy
- previous large bowel operations/ polypectomies
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 |
|---|---|---|
| ColonoscopyAlso: Endoscopy, Flexible endoscopyScreening colonoscopy | Procedure or surgery | Air, Carbon dioxide |
Primary outcome
duration of procedure
Time frame: 1 hour
Time from introduction of a colonoscope to removal of the colonoscope.
4 secondary outcomes
coecal intubation time
Time frame: 1 hour
pain immediately after the procedure
Time frame: 1 min
pain 15 minutes after colonoscopy
Time frame: 15 min
complication rate
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Results publication: PubMed 24915135Szura M, Pach R, Matyja A, Kulig J. Carbon dioxide insufflation during screening unsedated colonoscopy: a randomised clinical trial. Eur J Cancer Prev. 2015 Jan;24(1):37-43. doi: 10.1097/CEJ.0000000000000047.
Related trials for Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 2
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Chronic Rhinosinusitis With Nasal Polyps
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.
Miroslaw Szura, MD PhD study director
I Dept of General, Oncological and GI Surgery Jagiellonian University
Radoslaw Pach, MD PhD principal investigator
I Dept of General, Oncological and GI Surgery Jagiellonian University
Andrzej Matyja, MD PhD study chair
I Dept of General, Oncological and GI Surgery Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colonoscopy in people with Polyps, run by Jagiellonian University at 1 site in Poland.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jun 2014. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
duration of procedure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461564, which also lists 1 linked publication.
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 17 Jun 2014.