Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.
Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.
Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.
Procedure: Retroflexion with the adult colonoscope.
Procedure: Retroflexion with the pediatric colonoscope.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes|
- Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes. [ Time Frame: After 50% and 100% of patient enrollment is complete. ] [ Designated as safety issue: No ]
- Adenoma detection rate in forward and retroflexed views. [ Time Frame: After 50% and 100% of patient enrollment is complete. ] [ Designated as safety issue: No ]
- Reasons for failure of retroflexion. [ Time Frame: After 50% and 100% of patient enrollment is complete. ] [ Designated as safety issue: No ]This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.
|Study Start Date:||February 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Adult colonoscope
Use of the adult colonoscope.
|Procedure: Retroflexion with the adult colonoscope.|
Active Comparator: Pediatric colonoscope
Use of the pediatric colonoscope.
|Procedure: Retroflexion with the pediatric colonoscope.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675934
|United States, Wisconsin|
|Froedtert Surgery Center|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Young Oh, MD||Medical College of Wisconsin|