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NCT00905554 Clinical Trial

Warm Water for Unsedated Colonoscopy

Colonoscopy Clinical Trial

— WW  

Official title:
Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00905554
Other study ID # WW01
Secondary ID
Status Completed
Phase N/A
First received May 15, 2009
Last updated September 15, 2011
Start date April 2009
Est. completion date February 2010

Study information
Verified date September 2011
Source Valduce Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 230
Est. completion date February 2010
Est. primary completion date July 2009
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), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• warm water irrigation
warm water irrigation during insertion phase of colonoscopy
• air insufflation
air insufflation during the insertion phase of colonoscopy

Locations
Country Name City State
Italy Valduce Hospital Como CO

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 6-9 months No
Secondary Evaluation of Pain and Tolerability Scores 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) 6-9 months No
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