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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline; through study completion, an average of 8 year
2

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)

Time frame
Baseline; through study completion, an average of 8 year
3

Percentage of patients with the development of comorbidities.

Presence or absence of other comorbidities.

Time frame
Baseline; through study completion, an average of 8 year
4

Percentage of patients with extraintestinal manifestations (EIMs).

Presence or absence of extraintestinal manifestations.

Time frame
Baseline; through study completion, an average of 8 year

Secondary outcomes

1

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

Time frame
Baseline; through study completion, an average of 8 year
2

IBD-Q score

Inflammatory Bowel Disease - Questionnaire (validated questionnaire).

Time frame
Baseline; through study completion, an average of 8 year
3

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.

Time frame
Baseline; through study completion, an average of 8 year
4

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.

Time frame
Baseline; through study completion, an average of 8 year

Other outcomes

Sponsors and contacts

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