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

• Sponsor: Valduce Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01259583
• Collaborator: (none)
• Enrollment: 341
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 67.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 341 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of patients undergoing complete unsedated colonoscopy [6 months]

Secondary Outcome Measures

1. evaluation of pain and tolerability scores [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valduce Hospital - Gastroenterology Department	Como		Italy	22100

Sponsors and Collaborators

• Valduce Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arnaldo Amato, Doctor, Valduce Hospital
• ClinicalTrials.gov Identifier: NCT01259583
• Other Study ID Numbers: CO2-01
• First Posted: Dec 14, 2010
• Last Update Posted: Mar 13, 2013
• Last Verified: Mar 1, 2013

Study Results

No Results Posted as of Mar 13, 2013