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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.
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).
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with aggressive disease progression. | Occurrence, at least once during the natural history of the patient's disease, of one or more characteristics of aggressiveness, namely:
| Baseline; through study completion, an average of 8 year |
| Percentage of fragility patients. | Presence of one or more characteristics of frailty, namely:
| Baseline; through study completion, an average of 8 year |
| Percentage of patients with the development of comorbidities. | Presence or absence of other comorbidities. | Baseline; through study completion, an average of 8 year |
| Percentage of patients with extraintestinal manifestations (EIMs). | Presence or absence of extraintestinal manifestations. | Baseline; through study completion, an average of 8 year |
| Percentage of patients who underwent surgery. | Number of surgical interventions for luminal disease (defined as disease affecting one or more segments of the gastrointestinal tract). Number of surgical interventions for perianal disease (defined as the presence of perianal fistulas, abscesses, ulcers, and anal strictures). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with an adverse drug reaction. | Occurrence of adverse drug reactions classified by:
| Baseline; through study completion, an average of 8 year |
| IBD-Q score |
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Inclusion Criteria:
Exclusion Criteria:
- None
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The population consists of adult patients with IBD being followed at the Regional Reference Center "Massimo Campieri," which includes the General Surgery Unit and the IBD Specialties Unit of IRCCS AOUBO for the management of intestinal and extraintestinal conditions. Enrollment will take place in the IBD Specialties Unit during follow-up outpatient visits, hospital admissions, or through a phone/email invitation conducted by staff affiliated with the Unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Rizzello, MD | Contact | +39 0512145312 | fernando.rizzello@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Rizzello, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Baseline; through study completion, an average of 8 year |
| Percentage of patients with post-surgical complications. | Presence of one or more of the following elements:
| Baseline; through study completion, an average of 8 year |
| Percentage of patients with a diagnosis of neoplastic disease. | Presence and typing of the neoplasm, confirmed by instrumental/radiological findings and histological verification. | Baseline; through study completion, an average of 8 year |
| Percentage of patients with drug resistance. | Failure:
| Baseline; through study completion, an average of 8 year |
Inflammatory Bowel Disease - Questionnaire (validated questionnaire). |
| Baseline; through study completion, an average of 8 year |
| Percentage of gastrointestinal and non-gastrointestinal infections. | Assessment of the presence or absence of infections, including the type of infection/etiology if available, diagnosed through specific serology or culture tests. | Baseline; through study completion, an average of 8 year |
| Overall survival (OS) after the diagnosis of neoplastic/infectious disease. | Days elapsed between the date of diagnosis of neoplasia/infection and the date of death. | Baseline; through study completion, an average of 8 year |
| Evaluation of the ergonomics of the tool and its data analysis performance. | Introduction of a specific VAS scale for evaluating performance. | Baseline; through study completion, an average of 8 year |