Warm Water for Unsedated Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Procedure: air insufflation; Procedure: warm water irrigation

• Registration Number: NCT00905554
• Lead Sponsor: Valduce Hospital

Brief Summary

Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-20
• Primary Completion: 2009-07
• Study Completion: 2010-02
• Results First Submitted: 2011-08-05
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-15
• Last Update Submitted: 2011-09-15
• Results First Posted: 2011-10-25
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air	air insufflation	air insufflation during the insertion phase of colonoscopy
warm water	warm water irrigation	warm water irrigation during the insertion phase of colonoscopy

Primary Outcome Measures

Name	Time	Method
Number of Patients Undergoing Complete Unsedated Colonoscopy	6-9 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of Pain and Tolerability Scores	6-9 months	Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)

Trial Locations

Locations (1)

Valduce Hospital; 🇮🇹 Como, CO, Italy