RCT of Air Insufflation Versus Water Infusion Colonoscopy
NCT ID: NCT00785889
Last Updated: 2008-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2008-03-31
2008-10-31
Brief Summary
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Detailed Description
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Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SCREENING
SINGLE
Interventions
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water infusion colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eligible for colorectal cancer screening or surveillance
Exclusion Criteria
45 Years
75 Years
ALL
Yes
Sponsors
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East Bay Institute for Research and Education
OTHER
Responsible Party
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GI Section, Northern California Health Care System
Principal Investigators
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Joseph Leung, MD
Role: PRINCIPAL_INVESTIGATOR
Sacramento VA Medical Center, GI Section
Locations
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Sacramento VA Medical Center, VANCHCS
Mather, California, United States
Countries
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References
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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.
Leung 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.
Leung 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.
Leung 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.
Other Identifiers
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EBIRE-GI-001
Identifier Type: -
Identifier Source: org_study_id
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