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Endoscopic Quality Improvement Program (EQUIP)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01415817
First received: August 8, 2011
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Adenomatous Polyps
Colorectal Polyps
 Other: Training session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Measurement of overall adenoma detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Primary outcome measures will include overall and per patient adenoma detection rate for polypoid and non polypoid neoplastic lesions.


Secondary Outcome Measures:
  • Measurement of total polypectomy rate [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),

  • Measurement of colonoscopy time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Total colonoscopy time and endoscopist acceptance. Variables such as patient demographics and prep quality will be adjusted for.

  • Endoscopist Acceptance [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Ensdoscopist acceptance rate will be measured. Variables such as patient demographics and prep quality will be adjusted for.


Enrollment: 15
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline Data collection
Experimental: Randomization and Training Arm Other: Training session
Series of two training sessions after the first phase of study followed by monthly feedback.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415817

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael B. Wallace, MD,MPH Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Michael B. Wallace, Mayo Clinic Florida
ClinicalTrials.gov Identifier: NCT01415817     History of Changes
Other Study ID Numbers: 10-000433
Study First Received: August 8, 2011
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Quality Improvement
Adenoma Detection Rate
Polyp detection rate
 Colonoscopy
Training
Colorectal cancer screening

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

ClinicalTrials.gov processed this record on May 21, 2013