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

NCT ID: NCT06775951

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2025-10-01

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.

Conditions

Colorectal Cancer Control and Prevention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Fuccio, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Fuccio, MD

Role: CONTACT

lorenzo.fuccio3@unibo.it

0039 0512143338

Facility Contacts

Lorenzo Fuccio, MD

Role: primary

lorenzo.fuccio@aosp.bo.it

0512143338

Other Identifiers

PROMOTE

Identifier Type: -

Identifier Source: org_study_id