Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
1 other identifier
interventional
229
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
May 1, 2017
CompletedMay 1, 2017
March 1, 2017
9 months
May 1, 2008
January 17, 2017
March 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colonoscopy Success With Minimal Sedation
At the time of the procedure
Secondary Outcomes (2)
Time to Cecum
At the time of the procedure
Patient Satisfaction
At the time of the procedure
Study Arms (2)
Water Immersion Colonoscopy
EXPERIMENTALWater Immersion Colonoscopy
Standard Air Colonoscopy
ACTIVE COMPARATORStandard Air Colonoscopy
Interventions
instillation of 300cc of water in the rectum
air instillation in colon for visualization
Eligibility Criteria
You may qualify if:
- presentation for colonoscopy
- male
- age 18 or older
You may not qualify if:
- women
- known inflammatory bowel disease
- presentation for emergency colonoscopy
- history of partial colectomy
- chronic narcotic or benzodiazepine use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Related Publications (1)
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. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.
PMID: 20593332DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tonya Kaltenbach
- Organization
- San Francisco VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Soetikno, MD, MS
VA Palo Alto/Stanford University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 1, 2008
First Posted
May 5, 2008
Study Start
September 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
May 1, 2017
Results First Posted
May 1, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share