Endoscopic Quality Improvement Program

Overview

Effective colorectal cancer (CRC) screening relies on early identification and removal of both polypoid and non-polypoid lesions with neoplastic potential. The investigators hypothesize that an intensive training program designed to enhance both recognition and classification of lesions with neoplastic potential, will result in an increase in non-polypoid adenoma detection in addition to and independent of an increase in overall adenoma detection rates.

Full Title of Study: “The Effect of an Intensive Endoscopic Quality Improvement Program (EQUIP) on Improved Detection and Classification of Non-polypoid (Flat and Depressed) and Polypoid Colorectal Adenomas. (“EQUIP” Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Detailed Description

Our Endoscopic Quality Improvement Program (EQUIP) was a prospective educational intervention with our staff endoscopist as our study population. The investigators measured adenoma detection rates for a baseline period then randomly assigned half of the endoscopists to undergo EQUIP training. The investigators then examined baseline and post-training study adenoma detection rates (ADR's) for all endoscopist (trained and un-trained) to evaluate the impact of training.

Interventions

  • Other: Training session
    • Series of two training sessions after the first phase of study followed by monthly feedback.

Arms, Groups and Cohorts

  • No Intervention: Baseline Data collection
  • Experimental: Randomization and Training Arm

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of overall adenoma detection rate
    • Time Frame: 1 year
    • Primary outcome measures will include overall and per patient adenoma detection rate for polypoid and non polypoid neoplastic lesions.

Secondary Measures

  • Measurement of total polypectomy rate
    • Time Frame: 1 Year
    • Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),
  • Measurement of colonoscopy time
    • Time Frame: 1 Year
    • Total colonoscopy time and endoscopist acceptance. Variables such as patient demographics and prep quality will be adjusted for.
  • Endoscopist Acceptance
    • Time Frame: 1 Year
    • Ensdoscopist acceptance rate will be measured. Variables such as patient demographics and prep quality will be adjusted for.

Participating in This Clinical Trial

Inclusion Criteria

  • Colonoscopies performed at Mayo clinic ambulatory surgical center Exclusion Criteria:

  • Procedures for the indication of acute GI hemorrhage – Active colitis – Hereditary polyposis syndrome – Inflammatory bowel disease – Incomplete procedures – Procedures with surgically altered anatomy (i.e. prior colectomy) – Poor bowel preparation (Boston Bowel preparation score <5) were also excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Michael B. Wallace, Mayo Clinic Florida
  • Overall Official(s)
    • Michael B. Wallace, MD,MPH, Principal Investigator, Mayo Clinic

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