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

Recruiting

• Conditions: Colorectal Cancer Control and Prevention

• Registration Number: NCT06775951
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Colonoscopy is the most frequently conducted endoscopic examination in industrialized countries, occupying a considerable number of personnel and resources. However, colonoscopy is often over-prescribed, resulting in great waste of resources and increased risk to the patient with no discernible benefit. Colonoscopy has many indications and needs precise prescribing criteria to avoid inappropriate use of resources, especially in an open-access health care system such as the Italian one, criteria recently systematized by EPAGE (European Panel for Appropriateness in Gastrointestinal Endoscopy) and ASGE (American Society for Gastrointestinal Endoscopy) based on a set of observational studies. In these studies, it has been shown that colonoscopies with an appropriate indication frequently find significant lesions compared with colonoscopies prescribed according to inappropriate criteria, which are often negative. 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.

Study Timeline

• Study Start: 2023-01-02
• Status Verified: 2024-12
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1410

Inclusion Criteria

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

Exclusion Criteria

• Investigations performed in an emergency/emergency setting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of colonoscopies	5 months	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.

Trial Locations

Locations (2)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy