Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique - Full Text View

Sponsored by:	VA Palo Alto Health Care System
Information provided by:	VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:	NCT00671177

Purpose

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.

Condition	Intervention
Colonoscopy Digestive System Endoscopy Gastrointestinal Disease	Procedure: water immersion colonoscopy Procedure: standard air colonoscopy

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy Drinking Water Endoscopy

U.S. FDA Resources

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:

assess cecal intubation success using water immersion colonoscopy [ Time Frame: every 3 months or once enrollment complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to cecum [ Time Frame: every 3 months or once study enrollment complete ] [ Designated as safety issue: No ]
patient satisfaction [ Time Frame: every 3 months or once study enrollment complete ] [ Designated as safety issue: No ]

Enrollment:	229
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Water Immersion Colonoscopy	Procedure: water immersion colonoscopy instillation of 300cc of water in the rectum
2: Active Comparator Standard Air Colonoscopy	Procedure: standard air colonoscopy air instillation in colon for visualization

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671177

Locations

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304

Sponsors and Collaborators

VA Palo Alto Health Care System

Investigators

Principal Investigator:

Roy Soetikno, MD, MS

VA Palo Alto/Stanford University Medical Center

More Information

No publications provided

Responsible Party:	VA Palo Alto/Stanford University Medical Center ( Roy Soetikno, MD, MS )
Study ID Numbers:	Protocol10642
Study First Received:	May 1, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00671177 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:

colonoscopy
diagnostic techniques
digestive system
endoscopy
gastrointestinal

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 03, 2009