We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259583
First Posted: December 14, 2010
Last Update Posted: March 13, 2013
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.
Information provided by (Responsible Party):
Arnaldo Amato, Valduce Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)

Resource links provided by NLM:


Further study details as provided by Arnaldo Amato, Valduce Hospital:

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

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

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

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 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01259583


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

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
First Submitted: December 13, 2010
First Posted: December 14, 2010
Last Update Posted: March 13, 2013
Last Verified: March 2013