Pain, SatisfactionNCT00660296
Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
A study testing Air insufflation use in colonoscopy and CO2 use in colonoscopy in people with Pain, Satisfaction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Satisfaction
- What is being tested?
- Air insufflation use in colonoscopy and CO2 use in colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to Oct 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
- Between 18 and 90 years
Who cannot join
- COPD
- Dementia
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Dr. Anton Friedrich Weiser
Vienna, State of Vienna, 1230
Anton Weiser, MD, MSc, 43-1813-7934, dr.weiser@medway.at
Stefan Riss, MD
About this study
CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.
The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.
- Conditions
- Pain, Satisfaction
- Being tested
- Air insufflation use in colonoscopy, CO2 use in colonoscopy
- Keywords
- CO2, pain, colonoscopy, cancer, screening
- Medical subject headings
- Pain, Personal Satisfaction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air insufflation use in colonoscopyOther
Air insufflation for colonic distension
CO2 use in colonoscopyOther
Co2 insufflation for colonic distension
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Air insufflation in colonoscopy Receives: Other: Air insufflation use in colonoscopy |
| 1 | Other | CO2 insufflation in colonoscopy Receives: Other: CO2 use in colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after Colonoscopy measured by 100mm visual analogue scale.
Measured: 15 and 30 minutes and 6 h and 12 h after colonoscopy
Secondary outcomes (1)
patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions)
Measured: 30 minutes and 6 hours after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
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 Pain, SatisfactionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Riss, MD, Principal investigator, Medical University of ViennaAnton Weiser, MD, Principal investigator, Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660296
- Sponsor's protocol ID
- EK 07-238-VK
- Status last verified
- Apr 2008
- First submitted
- 14 Apr 2008
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bretthauer M, Lynge AB, Thiis-Evensen E, Hoff G, Fausa O, Aabakken L. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy. 2005 Aug;37(8):706-9. doi: 10.1055/s-2005-870154.
PubMed 16032487
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
- ClinicalTrials.gov ID
- NCT00660296
- Acronym / sponsor ID
- EK 07-238-VK
- Conditions
- Pain, Satisfaction
- Keywords
- CO2, pain, colonoscopy, cancer, screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 17 Apr 2008 (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.
CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.
The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Other: Air insufflation use in colonoscopyAir insufflation in colonoscopy |
| 1 | Other | Other: CO2 use in colonoscopyCO2 insufflation in colonoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
- Between 18 and 90 years
Key exclusion criteria (2 listed)
- COPD
- Dementia
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 |
|---|---|---|
| Air insufflation use in colonoscopyAir insufflation for colonic distension | Other | 2 |
| CO2 use in colonoscopyCo2 insufflation for colonic distension | Other | 1 |
Primary outcome
Pain after Colonoscopy measured by 100mm visual analogue scale.
Time frame: 15 and 30 minutes and 6 h and 12 h after colonoscopy
1 secondary outcome
patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions)
Time frame: 30 minutes and 6 hours after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2008.
- Results publication: PubMed 16032487Bretthauer M, Lynge AB, Thiis-Evensen E, Hoff G, Fausa O, Aabakken L. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy. 2005 Aug;37(8):706-9. doi: 10.1055/s-2005-870154.
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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.
Stefan Riss, MD principal investigator
Medical University of Vienna
Anton Weiser, MD principal investigator
Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air insufflation use in colonoscopy and CO2 use in colonoscopy in people with Pain, Satisfaction, run by Medical University of Vienna at 1 site in Austria.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Apr 2008. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Riss, MD (43-40-400-5621, stefan.riss@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after Colonoscopy measured by 100mm visual analogue scale. (time frame: 15 and 30 minutes and 6 h and 12 h after colonoscopy). 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 NCT00660296, 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 Apr 2008.