Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Not Applicable

Withdrawn

• Conditions: Colonic Neoplasms
• Interventions: Procedure: Retroflexion with the adult colonoscope.; Procedure: Retroflexion with the pediatric colonoscope.

• Registration Number: NCT01675934
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients over the age 18 undergoing screening or surveillance colonoscopy

Exclusion Criteria

• Age less than 18
• Pregnant
• History of ulcerative colitis or Crohn's disease
• History of polyposis syndromes
• History of colon resection
• Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult colonoscope	Retroflexion with the adult colonoscope.	Use of the adult colonoscope.
Pediatric colonoscope	Retroflexion with the pediatric colonoscope.	Use of the pediatric colonoscope.

Primary Outcome Measures

Name	Time	Method
Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.	After 50% and 100% of patient enrollment is complete.

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate in forward and retroflexed views.	After 50% and 100% of patient enrollment is complete.
Reasons for failure of retroflexion.	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.

Trial Locations

Locations (1)

Froedtert Surgery Center; 🇺🇸 Milwaukee, Wisconsin, United States