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Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by R. Keith Fincher, MD, FACP, FACG, Department of Defense.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01713881
First Posted: October 25, 2012
Last Update Posted: March 20, 2014
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.
Information provided by (Responsible Party):
R. Keith Fincher, MD, FACP, FACG, Department of Defense
  Purpose
This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).

Condition
Colon Polyp Surveillance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations

Resource links provided by NLM:


Further study details as provided by R. Keith Fincher, MD, FACP, FACG, Department of Defense:

Primary Outcome Measures:
  • Percentage completing follow up colonoscopy [ Time Frame: 12 months ]
    A polyp tracking program (registry) decreases the amount of patients lost to follow up.


Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
post-registry

Registry Group:

  • Select 500 consecutive patients from the polyp registry who were found to have a tubular adenoma on a colonoscopy done between 2007-2008 from the polyp registry.
  • Quantify the completion rate and time between index and surveillance colonoscopy after the establishment of the polyp surveillance program (2006-2013).
pre-registry
Pre-registry Group: Select 380 consecutive patients who were found to have a tubular adenoma on a colonoscopy done between April 2004-Nov 2006.

Detailed Description:
This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of 380-500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colon polyps
Criteria

Inclusion Criteria:

  • Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380)
  • Greater than 18 years old

Exclusion Criteria:

  • Less than 18 years old
  • Diagnosis of IBD
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01713881


Locations
United States, Georgia
D.D. Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905
Sponsors and Collaborators
United States Department of Defense
  More Information

Responsible Party: R. Keith Fincher, MD, FACP, FACG, Gastroenterologist, Department of Defense
ClinicalTrials.gov Identifier: NCT01713881     History of Changes
Other Study ID Numbers: DDEAMC-Fincher 1
First Submitted: October 23, 2012
First Posted: October 25, 2012
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by R. Keith Fincher, MD, FACP, FACG, Department of Defense:
Polyp
colonoscopy
surveillance

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms