Appropriateness of Colonoscopy Indication: an Evaluation... | NCT06775951

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

NCT06775951

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Jan 15, 2025Actual

Enrollment

1,410Estimated

Phase

Not provided

Conditions

Colorectal Cancer Control and Prevention

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2023Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Jan 10, 2025

First Submission Date that Met QC Criteria

Jan 10, 2025

First Posted Date

Jan 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2025

Last Update Posted Date

Jan 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,410Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lorenzo Fuccio, MD	Contact	0039 0512143338		lorenzo.fuccio3@unibo.it

Overall Officials

Name	Affiliation	Role
Lorenzo Fuccio, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero - Universitaria di Bologna	Recruiting	Bologna		40138	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided