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Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

NCT ID: NCT06721767

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2034-07-01

Brief Summary

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The study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. Specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.

Detailed Description

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The total duration of the study is expected to be 10 years. Partial analyses will be conducted during the study for data publication. The clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the Principal Investigator in an electronic Case Report Form (CRF).

Analysis Methodology:

Descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. Continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. Discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies.

To study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and Odds Ratios with 95% confidence intervals (OR - CI 95%) will be calculated.

The calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (CI 95%). Analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities.

Data will be processed using IBM SPSS statistical software (version 25.0).

Conditions

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IBD - Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age \> 14 years
* Diagnosis of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Microscopic Colitis) according to ECCO guidelines
* Having undergone at least one outpatient visit and/or hospitalization at the Regional Reference Center for IBD "Massimo Campieri"
* Acquisition of written informed consent from the patient and/or both parents/legal guardian

Exclusion Criteria

\- None
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Rizzello, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fernando Rizzello, MD

Role: CONTACT

Phone: +39 0512145312

Email: [email protected]

Facility Contacts

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Fernando Rizzello, MD

Role: primary

Other Identifiers

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OMNIA

Identifier Type: -

Identifier Source: org_study_id