Back to resultsEndoscopic Quality Improvement Program (EQUIP)
Primary Purpose
Adenomatous Polyps, Colorectal Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training session
Sponsored by
About this trial
This is an interventional other trial for Adenomatous Polyps focused on measuring Quality Improvement, Adenoma Detection Rate, Polyp detection rate, Colonoscopy, Training, Colorectal cancer screening
Eligibility 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.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Baseline Data collection
Randomization and Training Arm
Arm Description
Outcomes
Primary Outcome Measures
Measurement of overall adenoma detection rate
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
Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),
Measurement of colonoscopy time
Total colonoscopy time and endoscopist acceptance. Variables such as patient demographics and prep quality will be adjusted for.
Endoscopist Acceptance
Ensdoscopist acceptance rate will be measured. Variables such as patient demographics and prep quality will be adjusted for.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01415817
Brief Title
Endoscopic Quality Improvement Program
Acronym
EQUIP
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps, Colorectal Polyps
Keywords
Quality Improvement, Adenoma Detection Rate, Polyp detection rate, Colonoscopy, Training, Colorectal cancer screening
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline Data collection
Arm Type
No Intervention
Arm Title
Randomization and Training Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Training session
Intervention Description
Series of two training sessions after the first phase of study followed by monthly feedback.
Primary Outcome Measure Information:
Title
Measurement of overall adenoma detection rate
Description
Primary outcome measures will include overall and per patient adenoma detection rate for polypoid and non polypoid neoplastic lesions.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measurement of total polypectomy rate
Description
Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),
Time Frame
1 Year
Title
Measurement of colonoscopy time
Description
Total colonoscopy time and endoscopist acceptance. Variables such as patient demographics and prep quality will be adjusted for.
Time Frame
1 Year
Title
Endoscopist Acceptance
Description
Ensdoscopist acceptance rate will be measured. Variables such as patient demographics and prep quality will be adjusted for.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B. Wallace, MD,MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Quality Improvement Program
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