NCT03150238

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	observation of prognostic factors for relapse	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

Timeline

• Start date: 2017-04-13
• Primary completion: 2019-01-31
• Completion: 2019-05-31
• First posted: 2017-05-12
• Last updated: 2017-05-12

Locations

1 site across 1 country: Italy