Appropriateness of Colonoscopy Indication: an Evaluation of the Clinical and Economic Impact.

NCT06775951 | Recruiting

• 1 other identifier: PROMOTE
• Study Type: observational
• Target: 1,410
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.

Conditions

Colorectal Cancer Control and Prevention

Outcome Measures

Primary Outcomes (1)

• Number of colonoscopies

  Define the number of colonoscopies with indication appropriate out of the total number of colonoscopies performed, and quantify clinically relevant lesions and CCRs in appropriate and inappropriate colonoscopies.

  5 months

Study Arms (1)

Data collection for each patient on endoscopic examination

Data collection in patients undergoing colonoscopy, to identify the ability of the predictive model to predict colonoscopies with significant diagnostic findings, in patients already initiated for diagnostic examination as part of the normal care pathway.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participating subjects will undergo data collection at the same time as colonoscopy. After enrollment, information will be collected for each included patient regarding the demographic and clinical characteristics, the reason for prescription, and the diagnostic question proposed in congruity with EPAGE/ASGE criteria.

You may qualify if:

• Age \>18 years
• Patients undergoing outpatient and inpatient colonoscopy for any pathology, as part of the normal care process
• Obtaining informed consent.

You may not qualify if:

• Investigations performed in an emergency/emergency setting

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Lorenzo Fuccio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Fuccio, MD

CONTACT

0039 0512143338; lorenzo.fuccio3@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 2, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)