Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Colonic Neoplasms Clinical Trial

Official title:

Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01675934
• Other study ID #: PRO00017208
• Status: Withdrawn
• Phase: N/A
• First received: August 28, 2012
• Last updated: January 6, 2016
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2016
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Procedure:
• Retroflexion with the adult colonoscope.

• Retroflexion with the pediatric colonoscope.

Locations

Country	Name	City	State
United States	Froedtert Surgery Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Adenoma detection rate in forward and retroflexed views.		After 50% and 100% of patient enrollment is complete.	No
Secondary	Reasons for failure of retroflexion.	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.	After 50% and 100% of patient enrollment is complete.	No