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Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon

Primary Purpose

Colon Polyps, Colon Cancer Screening

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retroflexion in the right colon
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Polyps focused on measuring Colon Polyps, Colon Cancer screening, Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients >18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance

Exclusion Criteria:

  • • Failure to intubate the cecum during colonoscope insertion

    • Prior right colon resection
    • Known polyposis syndrome or polyposis identified at colonoscopy
    • Inflammatory bowel disease
    • Preparation of the colon is judged fair or poor using Boston Bowel Preparation Scale.

Sites / Locations

  • Washington University in St LouisRecruiting
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Retroflexion arm

Forward view arm

Arm Description

Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps

Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.

Outcomes

Primary Outcome Measures

Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.

Secondary Outcome Measures

Evaluate the success rate of retroflexion in the proximal colon.
Evaluate the percent of patients in whom retroflexion can be performed.
Identify risk factors for missing polyps on first examination of right colon
We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale

Full Information

First Posted
October 8, 2012
Last Updated
May 29, 2013
Sponsor
Washington University School of Medicine
Collaborators
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01704820
Brief Title
Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon
Official Title
RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Colonoscopy is the gold standard screening test for colorectal cancer. Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon cancers, it provides only limited protection from cancer in the proximal (right side) colon. Our goal is to determine if additional pre-cancerous colon polyps can be identified by looking at the right side of the colon in retroflexion. During retroflexion the tip of the colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If additional polyps can be identified in this manner colonoscopy will become a more efficient method of screening for colon cancer. In order to evaluate how effective right colon retroflexion is at detecting polyps in the proximal colon we plan on performing a randomized, controlled trial. Patients undergoing screening or follow up colonoscopy will be invited to participate in the study. Those patients who agree to participate will be randomized into one of two groups once the colonoscope is fully inserted. Group one will have the right side of their colon examined for polyps with the endoscope looking forward (traditional form of examination) followed by repeat examination of the right side of the colon with the colonosocpe in retroflexion (looking backwards). Polyps seen during each section of the exam will be removed and manner in which the polyps were found/ removed will be recorded. Following the two exams of the right side of the colon the colonoscopy will be completed in the usual manner. The duration of each portion of colonoscopy will be recorded. After the procedure is completed the physician performing the colonoscopy will rate difficulty of the procedure and confidence with quality of the examination. Pathology results for each polyp will be recorded once available. There will be no study related follow up after the pathology results are recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyps, Colon Cancer Screening
Keywords
Colon Polyps, Colon Cancer screening, Colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retroflexion arm
Arm Type
Experimental
Arm Description
Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps
Arm Title
Forward view arm
Arm Type
Placebo Comparator
Arm Description
Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.
Intervention Type
Procedure
Intervention Name(s)
Retroflexion in the right colon
Primary Outcome Measure Information:
Title
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
Description
The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Evaluate the success rate of retroflexion in the proximal colon.
Description
Evaluate the percent of patients in whom retroflexion can be performed.
Time Frame
1 day
Title
Identify risk factors for missing polyps on first examination of right colon
Description
We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
Time Frame
1 day
Title
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
Description
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
Time Frame
1 day
Title
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
Description
Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients >18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance Exclusion Criteria: • Failure to intubate the cecum during colonoscope insertion Prior right colon resection Known polyposis syndrome or polyposis identified at colonoscopy Inflammatory bowel disease Preparation of the colon is judged fair or poor using Boston Bowel Preparation Scale.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir M Kushnir, MD
Phone
3144548201
Email
vkushnir@wustl.edu
Facility Information:
Facility Name
Washington University in St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir M Kushnir, MD
Phone
314-454-8201
Email
vkushnir@wustl.edu
First Name & Middle Initial & Last Name & Degree
Early Dayna, MD
Facility Name
Medical College of Wisconsin
City
Milwaukie
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young (Danny) Oh, MD
Phone
414-955-6836
Email
yoh@mcw.edu
First Name & Middle Initial & Last Name & Degree
Young (Danny) Oh, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21679946
Citation
Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
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Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon

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