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

Last updated: December 3, 2024
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT06721767
OMNIA
  • Ages > 14
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theRegional Reference Center for IBD "Massimo Campieri"

  • Acquisition of written informed consent from the patient and/or both parents/legalguardian

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 10000
Study Start date:
January 08, 2024
Estimated Completion Date:
July 01, 2034

Study Description

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).

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.