Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IBD - Inflammatory Bowel Disease. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
Overview
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
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).
Primary outcome measures
- Percentage of patients with aggressive disease progression. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of fragility patients. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients with the development of comorbidities. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients with extraintestinal manifestations (EIMs). [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients who underwent surgery. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients with post-surgical complications. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients with a diagnosis of neoplastic disease. [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of patients with drug resistance. [Time frame: Baseline; through study completion, an average of 8 year]
Secondary outcome measures (5)
- Percentage of patients with an adverse drug reaction. [Time frame: Baseline; through study completion, an average of 8 year]
- IBD-Q score [Time frame: Baseline; through study completion, an average of 8 year]
- Percentage of gastrointestinal and non-gastrointestinal infections. [Time frame: Baseline; through study completion, an average of 8 year]
- Overall survival (OS) after the diagnosis of neoplastic/infectious disease. [Time frame: Baseline; through study completion, an average of 8 year]
- Evaluation of the ergonomics of the tool and its data analysis performance. [Time frame: Baseline; through study completion, an average of 8 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06721767 · OMNIA