RCT of Air Insufflation Versus Water Infusion Colonoscopy
A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
1 other identifier
interventional
56
1 country
1
Brief Summary
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Mar 2008
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedNovember 14, 2008
November 1, 2008
6 months
November 3, 2008
November 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increments of medications used for sedation
duration of procedure
Secondary Outcomes (3)
pain scores during colonoscopy
duration of procedure
success with cecal intubation
during procedure
willingness to repeat colonoscopy
after procedure
Interventions
water infusion in lieu of air insufflation for screening colonoscopy
Eligibility Criteria
You may qualify if:
- healthy individual 50 years or older
- eligible for colorectal cancer screening or surveillance
You may not qualify if:
- patients who do not understand or failed to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sacramento VA Medical Center, VANCHCS
Mather, California, 95655, United States
Related Publications (4)
Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.
PMID: 17661766BACKGROUNDLeung FW. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008 Nov;53(11):2847-50. doi: 10.1007/s10620-008-0259-1. Epub 2008 May 7.
PMID: 18461455BACKGROUNDLeung FW, Aharonian HS, Guth PH, Chu SK, Nguyen BD, Simpson P. Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience. Gastrointest Endosc. 2008 Apr;67(4):718-22. doi: 10.1016/j.gie.2007.11.040.
PMID: 18374030BACKGROUNDLeung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
PMID: 19555938DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Leung, MD
Sacramento VA Medical Center, GI Section
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
November 14, 2008
Record last verified: 2008-11