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Endoscopic Quality Improvement Program (EQUIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415817
First Posted: August 12, 2011
Last Update Posted: August 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  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: None (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)

Further study details as provided by Mayo Clinic:

Primary Outcome 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 Outcome 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael B. Wallace, Mayo Clinic Florida
ClinicalTrials.gov Identifier: NCT01415817     History of Changes
Other Study ID Numbers: 10-000433
First Submitted: August 8, 2011
First Posted: August 12, 2011
Last Update Posted: August 12, 2011
Last Verified: August 2011

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
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms