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

The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

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.

Study Overview

• Status: Recruiting
• Conditions: IBD - Inflammatory Bowel Disease

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).

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Fernando Rizzello, MD; Phone Number: +39 0512145312; Email: fernando.rizzello@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Fernando Rizzello, MD; Phone Number: +390512145312; Email: fernando.rizzello@unibo.it
    • Principal Investigator: Fernando Rizzello, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Immunosuppressive/biotechnology/small molecule therapy due to failure of conventional therapy or severe disease; Surgery due to failure of medical therapy or the onset of complications such as strictures or fistulas; Endoscopic recurrence of disease post-surgery; Hospitalization for severe disease or the onset of complications	Baseline; through study completion, an average of 8 year
Percentage of fragility patients.	Presence of one or more characteristics of frailty, namely: Polypharmacy (defined as the need to take at least one other medication for a condition other than inflammatory bowel disease); Short bowel syndrome post-surgery (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) requiring supplemental enteral/parenteral nutrition; Osteoporosis (defined as bone mineral density - BMD - with a T-score less than -2.5) with or without pathological fractures; One or more extraintestinal manifestations (EIMs)	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).	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: Early complication (< 30 days) or late complication (> 30 days) post-surgery; Development of short bowel syndrome (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) post-surgery (if Crohn's disease); Need for major therapy post-surgery	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: Primary; Secondary; Primary failure refers to the lack of efficacy after the induction phase, while secondary failure refers to the loss of efficacy after initial benefit.	Baseline; through study completion, an average of 8 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with an adverse drug reaction.	Occurrence of adverse drug reactions classified by: Type of adverse drug event; Severity of the adverse event according to CTCAE 5.0	Baseline; through study completion, an average of 8 year
IBD-Q score	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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Fernando Rizzello, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): July 1, 2034

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: OMNIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No