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

Not Applicable

Completed

• Conditions: Warm Water; CO2 Colonoscopy; Unsedated Colonoscopy
• Interventions: Procedure: Warm water; Procedure: CO2

• Registration Number: NCT01259583
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

Not provided

Exclusion Criteria

• refuse to initiate colonoscopy without routine sedation
• inadequate bowel preparation
• incapacity to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm Water irrigation	Warm water	warm water irrigation during the insertion phase of colonoscopy
CO2	CO2	CO2 insufflation instead air insufflation in unsedated colonoscopy

Primary Outcome Measures

Name	Time	Method
number of patients undergoing complete unsedated colonoscopy	6 months

Secondary Outcome Measures

Name	Time	Method
evaluation of pain and tolerability scores	6 months

Trial Locations

Locations (1)

Valduce Hospital - Gastroenterology Department; 🇮🇹 Como, Italy