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

Condition(s) studied

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

Primary outcome measure(s)

• Percentage of patients with aggressive disease progression. — Baseline; through study completion, an average of 8 year
  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
• Percentage of fragility patients. — Baseline; through study completion, an average of 8 year
  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)
• Percentage of patients with the development of comorbidities. — Baseline; through study completion, an average of 8 year
  Presence or absence of other comorbidities.
• Percentage of patients with extraintestinal manifestations (EIMs). — Baseline; through study completion, an average of 8 year
  Presence or absence of extraintestinal manifestations.
• Percentage of patients who underwent surgery. — Baseline; through study completion, an average of 8 year
  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).
• Percentage of patients with post-surgical complications. — Baseline; through study completion, an average of 8 year
  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
• Percentage of patients with a diagnosis of neoplastic disease. — Baseline; through study completion, an average of 8 year
  Presence and typing of the neoplasm, confirmed by instrumental/radiological findings and histological verification.
• Percentage of patients with drug resistance. — Baseline; through study completion, an average of 8 year
  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.

Trial sites (1)

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