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

March 19, 2014 updated by: R. Keith Fincher, MD, FACP, FACG, United States Department of Defense

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).

Study Overview

Status

Unknown

Conditions

Colon Polyp Surveillance

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).

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Georgia
  - Fort Gordon, Georgia, United States, 30905
    - D.D. Eisenhower Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colon polyps

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage completing follow up colonoscopy Time Frame: 12 months	A polyp tracking program (registry) decreases the amount of patients lost to follow up.	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria