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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: observation of prognostic factors for relapse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-operative Crohn Disease patients<br>Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months | Other: observation of prognostic factors for relapse<br>* The identification of the most relevant prognostic factors and the definition of their weight in predict the risk of re-intervention will be the basis for the definition of a combined score<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate | re-operation rate | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months |