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

Unsedated Colonoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259583
• Other study ID #: CO2-01
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: March 12, 2013
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2013
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• CO2 Colonoscopy
• Unsedated Colonoscopy
• Warm Water

Intervention

Procedure:
• CO2
CO2 insufflation
• Warm water
warm water irrigation

Locations

Country	Name	City	State
Italy	Valduce Hospital - Gastroenterology Department	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients undergoing complete unsedated colonoscopy		6 months	No
Secondary	evaluation of pain and tolerability scores		6 months	No