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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
R. Keith Fincher, MD, FACP, FACG, Department of Defense
ClinicalTrials.gov Identifier:
NCT01713881
First received: October 23, 2012
Last updated: March 19, 2014
Last verified: March 2014
  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 Department of Defense:

Primary Outcome Measures:
  • Percentage completing follow up colonoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713881

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

No publications provided

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
Study First Received: October 23, 2012
Last Updated: March 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Defense:
Polyp
colonoscopy
surveillance

ClinicalTrials.gov processed this record on November 25, 2014