NCT01415817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

August 8, 2011

Last Update Submit

May 30, 2023

Conditions

Adenomatous PolypsColorectal Polyps

Keywords

Quality ImprovementAdenoma Detection RatePolyp detection rateColonoscopyTrainingColorectal cancer screening

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Measurement of total polypectomy rate

    1 Year

  • Measurement of colonoscopy time

    1 Year

  • Endoscopist Acceptance

    1 Year

Study Arms (2)

Baseline Data collection

NO INTERVENTION

Randomization and Training Arm

EXPERIMENTAL
Other: Training session

Interventions

Training sessionOTHER

Series of two training sessions after the first phase of study followed by monthly feedback.

Randomization and Training Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colonoscopies performed at Mayo clinic ambulatory surgical center

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Adenomatous Polyps

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Michael B. Wallace, MD,MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 12, 2011

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

US(1)