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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

May 1, 2008
January 28, 2009
September 2007
June 2008   (final data collection date for primary outcome measure)
assess cecal intubation success using water immersion colonoscopy [ Time Frame: every 3 months or once enrollment complete ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00671177 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Colonoscopy
  • Digestive System
  • Endoscopy
  • Gastrointestinal Disease
  • Procedure: water immersion colonoscopy
    instillation of 300cc of water in the rectum
  • Procedure: standard air colonoscopy
    air instillation in colon for visualization
  • Experimental: 1
    Water Immersion Colonoscopy
    Intervention: Procedure: water immersion colonoscopy
  • Active Comparator: 2
    Standard Air Colonoscopy
    Intervention: Procedure: standard air colonoscopy
Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. Epub 2010 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00671177
Protocol10642
Yes
Roy Soetikno, MD, MS, VA Palo Alto/Stanford University Medical Center
VA Palo Alto Health Care System
Not Provided
Principal Investigator: Roy Soetikno, MD, MS VA Palo Alto/Stanford University Medical Center
VA Palo Alto Health Care System
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP