Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative Crohn Disease patients | Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation of prognostic factors for relapse | Other | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wall sonographic thickness | Wall sonographic thickness will be measured, to define, if feasible, a precise cut-off of thickness that could predict the risk of re-intervention, by a correlation with Rutgeerts' score | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federica Furfaro, MD, PhD | Contact | +390282245555 | federica.furfaro@humanitas.it | |
| Silvio Danese, MD, PhD | Contact | +390282245555 | IBDclinicaltrias@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Federica Furfaro, MD, phD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Recruiting | Rozzano | MI | 20089 | Italy |
TO BE DETERMINED
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D007410 | Intestinal Diseases |