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
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

Additional relevant MeSH terms:
Adenoma
Colonic Polyps
Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014