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Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arnaldo Amato, Valduce Hospital
ClinicalTrials.gov Identifier:
NCT01259583
First received: December 13, 2010
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.


Condition Intervention
Warm Water
CO2 Colonoscopy
Unsedated Colonoscopy
 Procedure: CO2
Procedure: Warm water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • number of patients undergoing complete unsedated colonoscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluation of pain and tolerability scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 341
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CO2
CO2 insufflation instead air insufflation in unsedated colonoscopy
 Procedure: CO2
CO2 insufflation
Experimental: Warm Water irrigation
warm water irrigation during the insertion phase of colonoscopy
 Procedure: Warm water
warm water irrigation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259583

Locations
Italy
Valduce Hospital - Gastroenterology Department
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
  More Information

No publications provided by Valduce Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arnaldo Amato, Doctor, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01259583     History of Changes
Other Study ID Numbers: CO2-01
Study First Received: December 13, 2010
Last Updated: March 12, 2013
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013