Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

NCT01675934 | Withdrawn

• 1 other identifier: PRO00017208
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Adult colonoscope

ACTIVE COMPARATOR

Use of the adult colonoscope.

Procedure: Retroflexion with the adult colonoscope.

Pediatric colonoscope

ACTIVE COMPARATOR

Use of the pediatric colonoscope.

Procedure: Retroflexion with the pediatric colonoscope.

Interventions

Retroflexion with the adult colonoscope. PROCEDURE

Adult colonoscope

Retroflexion with the pediatric colonoscope. PROCEDURE

Pediatric colonoscope

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Surgery Center

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Young Oh, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)