Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
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|ClinicalTrials.gov Identifier: NCT01383252|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 17, 2013
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:
- Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
- Study method improves bowel preparation and increases polyp pickup rate
|Condition or disease||Intervention/treatment||Phase|
|Colon Polyp||Procedure: Water infusion in lieu of air insufflation Procedure: Air method||Not Applicable|
Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.
The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.
In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Water method
Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
Procedure: Water infusion in lieu of air insufflation
Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.
Active Comparator: Air method
Air insufflation for screening and surveillance colonoscopy
Procedure: Air method
Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.
Other Name: Screening colonoscopy
- Success of colonoscopy [ Time Frame: 24 months ]successful cecal intubation
- Polyp detection [ Time Frame: 24 months ]Adenoma detection rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383252
|United States, California|
|Sacramento VA Medical Center|
|Mather, California, United States, 95655|
|Principal Investigator:||Joseph Leung, MD||Sacramento VA Medical Center|