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Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Primary Purpose

Colonic Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retroflexion with the adult colonoscope.
Retroflexion with the pediatric colonoscope.
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Froedtert Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Adult colonoscope

Pediatric colonoscope

Arm Description

Use of the adult colonoscope.

Use of the pediatric colonoscope.

Outcomes

Primary Outcome Measures

Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.

Secondary Outcome Measures

Adenoma detection rate in forward and retroflexed views.
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.

Full Information

First Posted
August 28, 2012
Last Updated
January 6, 2016
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01675934
Brief Title
Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Official Title
Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
PI has left institution
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult colonoscope
Arm Type
Active Comparator
Arm Description
Use of the adult colonoscope.
Arm Title
Pediatric colonoscope
Arm Type
Active Comparator
Arm Description
Use of the pediatric colonoscope.
Intervention Type
Procedure
Intervention Name(s)
Retroflexion with the adult colonoscope.
Intervention Type
Procedure
Intervention Name(s)
Retroflexion with the pediatric colonoscope.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Adenoma detection rate in forward and retroflexed views.
Time Frame
After 50% and 100% of patient enrollment is complete.
Title
Reasons for failure of retroflexion.
Description
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.
Time Frame
After 50% and 100% of patient enrollment is complete.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Oh, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Surgery Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

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