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NCT00671177 Clinical Trial

Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Colonoscopy Clinical Trial

Official title:
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00671177
Other study ID # Protocol10642
Secondary ID
Status Completed
Phase N/A
First received May 1, 2008
Last updated January 28, 2009
Start date September 2007
Est. completion date June 2008

Study information
Verified date January 2009
Source VA Palo Alto Health Care System
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.

Recruitment information / eligibility
Status Completed
Enrollment 229
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- presentation for colonoscopy

- male

- age 18 or older

Exclusion Criteria:

- women

- known inflammatory bowel disease

- presentation for emergency colonoscopy

- history of partial colectomy

- chronic narcotic or benzodiazepine use

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• water immersion colonoscopy
instillation of 300cc of water in the rectum
• standard air colonoscopy
air instillation in colon for visualization

Locations
Country Name City State
United States VA Palo Alto Health Care System Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary assess cecal intubation success using water immersion colonoscopy every 3 months or once enrollment complete No
Secondary time to cecum every 3 months or once study enrollment complete No
Secondary patient satisfaction every 3 months or once study enrollment complete No
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