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

May 29, 2013 updated by: Washington University School of Medicine

RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St Louis
        • Contact:
        • Principal Investigator:
          • Early Dayna, MD
    • Wisconsin
      • Milwaukie, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
          • Young (Danny) Oh, MD
          • Phone Number: 414-955-6836
          • Email: yoh@mcw.edu
        • Principal Investigator:
          • Young (Danny) Oh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retroflexion arm
Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps
Procedure: Retroflexion in the right colon
Placebo Comparator: Forward view arm
Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
Time Frame: 2 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the success rate of retroflexion in the proximal colon.
Time Frame: 1 day
Evaluate the percent of patients in whom retroflexion can be performed.
1 day
Identify risk factors for missing polyps on first examination of right colon
Time Frame: 1 day
We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
1 day
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
Time Frame: 1 day
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
1 day
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
Time Frame: 1 day
Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retro-View

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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