- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415817
Endoscopic Quality Improvement Program (EQUIP)
May 30, 2023 updated by: Mayo Clinic
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
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
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Florida
-
-
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
Yes
Description
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.
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline Data collection
|
|
Experimental: Randomization and Training Arm
|
Series of two training sessions after the first phase of study followed by monthly feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of total polypectomy rate
Time Frame: 1 Year
|
Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),
|
1 Year
|
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.
|
1 Year
|
Endoscopist Acceptance
Time Frame: 1 Year
|
Ensdoscopist acceptance rate will be measured.
Variables such as patient demographics and prep quality will be adjusted for.
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael B. Wallace, MD,MPH, Mayo Clinic
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, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
August 8, 2011
First Submitted That Met QC Criteria
August 11, 2011
First Posted (Estimated)
August 12, 2011
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 30, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-000433
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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