We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00660296
Recruitment Status : Unknown
Verified April 2008 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Pain, Satisfaction Other: Air insufflation use in colonoscopy Other: CO2 use in colonoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
Study Start Date : February 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pain after Colonoscopy measured by 100mm visual analogue scale. [ Time Frame: 15 and 30 minutes and 6 h and 12 h after colonoscopy ]

Secondary Outcome Measures :
  1. patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions) [ Time Frame: 30 minutes and 6 hours after colonoscopy ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

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