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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704820
Recruitment Status : Unknown
Verified May 2013 by Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : October 11, 2012
Last Update Posted : May 31, 2013
Medical College of Wisconsin
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Colon Polyps Colon Cancer Screening Procedure: Retroflexion in the right colon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704820

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Contact: Vladimir M Kushnir, MD 3144548201

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United States, Missouri
Washington University in St Louis Recruiting
St Louis, Missouri, United States, 63110
Contact: Vladimir M Kushnir, MD    314-454-8201   
Principal Investigator: Early Dayna, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukie, Wisconsin, United States, 53226
Contact: Young (Danny) Oh, MD    414-955-6836   
Principal Investigator: Young (Danny) Oh, MD         
Sponsors and Collaborators
Washington University School of Medicine
Medical College of Wisconsin
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Responsible Party: Washington University School of Medicine Identifier: NCT01704820    
Other Study ID Numbers: Retro-View
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by Washington University School of Medicine:
Colon Polyps
Colon Cancer screening
Additional relevant MeSH terms:
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Colonic Neoplasms
Colonic Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Polyps