Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01675934|
Recruitment Status : Withdrawn (PI has left institution)
First Posted : August 30, 2012
Last Update Posted : January 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Procedure: Retroflexion with the adult colonoscope. Procedure: Retroflexion with the pediatric colonoscope.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.|
- 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. ]
- Adenoma detection rate in forward and retroflexed views. [ Time Frame: After 50% and 100% of patient enrollment is complete. ]
- Reasons for failure of retroflexion. [ Time Frame: After 50% and 100% of patient enrollment is complete. ]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.
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): NCT01675934
|United States, Wisconsin|
|Froedtert Surgery Center|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Young Oh, MD||Medical College of Wisconsin|