Adenomatous PolypsEQUIPNCT01415817
Endoscopic Quality Improvement Program
A study testing Training session in people with Adenomatous Polyps and Colorectal Polyps, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps, Colorectal Polyps
- What is being tested?
- Training session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Colonoscopies performed at Mayo clinic ambulatory surgical center
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Adenomatous Polyps, Colorectal Polyps
- Being tested
- Training session
- Keywords
- Quality Improvement, Adenoma Detection Rate, Polyp detection rate, Colonoscopy, Training, Colorectal cancer screening
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training sessionOther
Series of two training sessions after the first phase of study followed by monthly feedback.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Data collection | No intervention | Not described |
| Randomization and Training Arm | Experimental | Not described Receives: Other: Training session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Measurement of total polypectomy rate
Secondary outcomes will include total polypectomy rate (hyperplastic vs. adenoma),
Measured: 1 Year
Measurement of colonoscopy time
Total colonoscopy time and endoscopist acceptance. Variables such as patient demographics and prep quality will be adjusted for.
Measured: 1 Year
Endoscopist Acceptance
Ensdoscopist acceptance rate will be measured. Variables such as patient demographics and prep quality will be adjusted for.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Michael B. Wallace, MD,MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415817
- Sponsor's protocol ID
- 10-000433
- Acronym
- EQUIP
- Status last verified
- May 2023
- First submitted
- 8 Aug 2011
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01415817
- Acronym / sponsor ID
- EQUIP / 10-000433
- Conditions
- Adenomatous Polyps, Colorectal Polyps
- Keywords
- Quality Improvement, Adenoma Detection Rate, Polyp detection rate, Colonoscopy, Training, Colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Data collection | No intervention | – |
| Randomization and Training Arm | Experimental | Other: Training session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colonoscopies performed at Mayo clinic ambulatory surgical center
Key exclusion criteria (7 listed)
- Procedures for the indication of acute GI hemorrhage
- Active colitis
- Hereditary polyposis syndrome
- Inflammatory bowel disease
- Incomplete procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training sessionSeries of two training sessions after the first phase of study followed by monthly feedback. | Other | Randomization and Training Arm |
Primary outcome
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.
3 secondary outcomes
Measurement of total polypectomy rate
Time frame: 1 Year
Measurement of colonoscopy time
Time frame: 1 Year
Endoscopist Acceptance
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B. Wallace, MD,MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training session in people with Adenomatous Polyps and Colorectal Polyps, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of overall adenoma detection rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.