Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building

Istituto Clinico Humanitas220 enrolled

Overview

The project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. These data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. Approximately 220 adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months will be enrolled.

Patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). Patients will be stratified according to risk factors and type of treatment carried out in that year

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Crohn Disease

Interventions

observation of prognostic factors for relapse

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients aged 18 to 65 years, inclusive * Diagnosis of Crohn's Disease (CD) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence * First surgery for CD performed less than 6 months before enrolment (no second surgery allowed) * Ability to provide written informed consent and to be compliant with the schedule of protocol assessments Exclusion Criteria: * Diagnosis of ulcerative colitis or indeterminate colitis * Crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement * More than one surgery for luminal CD * Current stoma or need for ileostomy or colostomy * Clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator * Inability to provide written informed consent and poor compliance with the schedule of protocol assessments

Outcomes

Primary Outcomes

Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate

re-operation rate

Time frame: 12 months

Secondary Outcomes

Ideation of a new score for the risk of re-operation in CD patients

The identification of the prognostic relevant factor and the evaluation of their specific weight in predicting the risk of re-intervention will be the basis for the ideation of a new score for the risk of re-operation in CD patients.

Time frame: 12 months

Central Contacts

Federica Furfaro, MD, PhD

CONTACT

+390282245555 federica.furfaro@humanitas.it

Silvio Danese, MD, PhD