Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

This study is currently recruiting participants.

Verified by Medical University of Vienna, April 2008

First Received: April 14, 2008 Last Updated: April 16, 2008 History of Changes

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00660296

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:	Diagnostic, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

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:

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.

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

Keywords provided by Medical University of Vienna:

CO2
pain
colonoscopy
cancer
screening

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 11, 2009