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

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. Identifier: NCT01259583
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : March 13, 2013
Information provided by (Responsible Party):
Arnaldo Amato, Valduce Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Warm Water CO2 Colonoscopy Unsedated Colonoscopy Procedure: CO2 Procedure: Warm water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. number of patients undergoing complete unsedated colonoscopy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. evaluation of pain and tolerability scores [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01259583

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Arnaldo Amato, Doctor, Valduce Hospital Identifier: NCT01259583     History of Changes
Other Study ID Numbers: CO2-01
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013