Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Medical University of Vienna.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00660296
First received: April 14, 2008
Last updated: April 16, 2008
Last verified: April 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 14, 2008 | ||||||||
| Last Updated Date | April 16, 2008 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain after Colonoscopy measured by 100mm visual analogue scale. [ Time Frame: 15 and 30 minutes and 6 h and 12 h after colonoscopy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00660296 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions) [ Time Frame: 30 minutes and 6 hours after colonoscopy ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients | ||||||||
| Official Title ICMJE | Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
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| Condition ICMJE | Pain, Satisfaction | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | October 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00660296 | ||||||||
| Other Study ID Numbers ICMJE | EK 07-238-VK | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Medical University of Vienna | ||||||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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