Pain, Satisfaction Clinical Trial
Official title:
Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation - Between 18 and 90 years Exclusion Criteria: - COPD - Dementia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Austria | Dr. Anton Friedrich Weiser | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain after Colonoscopy measured by 100mm visual analogue scale. | 15 and 30 minutes and 6 h and 12 h after colonoscopy | No | |
| Secondary | patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions) | 30 minutes and 6 hours after colonoscopy | No |