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Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

This study has been completed.
Sponsor:
Information provided by:
VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT00671177
First received: May 1, 2008
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Resource links provided by NLM:

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
Experimental: 1
Water Immersion Colonoscopy
 Procedure: water immersion colonoscopy
instillation of 300cc of water in the rectum
Active Comparator: 2
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 by VA Palo Alto Health Care System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by VA Palo Alto Health Care System:
colonoscopy
diagnostic techniques
digestive system
endoscopy
gastrointestinal

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 13, 2013