Trial record 3 of 46 for:    Open Studies | "Colonic Polyps"

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

This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01704820
First received: October 8, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Intervention
Colon Polyps
Colon Cancer Screening
Procedure: Retroflexion in the right colon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Evaluate the percent of patients in whom retroflexion can be performed.

  • Identify risk factors for missing polyps on first examination of right colon [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale


Estimated Enrollment: 1020
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704820

Contacts
Contact: Vladimir M Kushnir, MD 3144548201 vkushnir@wustl.edu

Locations
United States, Missouri
Washington University in St Louis Recruiting
St Louis, Missouri, United States, 63110
Contact: Vladimir M Kushnir, MD    314-454-8201    vkushnir@wustl.edu   
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    yoh@mcw.edu   
Principal Investigator: Young (Danny) Oh, MD         
Sponsors and Collaborators
Washington University School of Medicine
Medical College of Wisconsin
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01704820     History of Changes
Other Study ID Numbers: Retro-View
Study First Received: October 8, 2012
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Colon Polyps
Colon Cancer screening
Colonoscopy

Additional relevant MeSH terms:
Colonic Polyps
Colonic Neoplasms
Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014