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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
Sponsor:
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
  Purpose

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.


Condition Intervention
Pain, Satisfaction
Other: Air insufflation use in colonoscopy
Other: CO2 use in colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: February 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
Air insufflation in colonoscopy
Other: Air insufflation use in colonoscopy
Air insufflation for colonic distension
1
CO2 insufflation in colonoscopy
Other: CO2 use in colonoscopy
Co2 insufflation for colonic distension

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660296

Contacts
Contact: Stefan Riss, MD 43-40-400-5621 stefan.riss@meduniwien.ac.at

Locations
Austria
Dr. Anton Friedrich Weiser Recruiting
Vienna, Austria, 1230
Contact: Anton Weiser, MD, MSc    43-1813-7934    dr.weiser@medway.at   
Principal Investigator: Stefan Riss, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stefan Riss, MD Medical University of Vienna
Principal Investigator: Anton Weiser, MD Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna
  More Information

Publications:
Responsible Party: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00660296     History of Changes
Other Study ID Numbers: EK 07-238-VK
Study First Received: April 14, 2008
Last Updated: April 16, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
CO2
pain
colonoscopy
cancer
screening

ClinicalTrials.gov processed this record on November 20, 2014