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

• Conditions: Crohn Disease
• Interventions: Other: observation of prognostic factors for relapse

• Registration Number: NCT03150238
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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

Study Timeline

• Study Start: 2017-04-13
• Status Verified: 2017-05
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Study First Posted: 2017-05-12
• Last Update Posted: 2017-05-12
• Primary Completion: 2019-01-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-operative Crohn Disease patients	observation of prognostic factors for relapse	Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months

Primary Outcome Measures

Name	Time	Method
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate	12 months	re-operation rate

Secondary Outcome Measures

Name	Time	Method
Ideation of a new score for the risk of re-operation in CD patients	12 months	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.

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy