Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building
NCT ID: NCT03150238
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
220 participants
OBSERVATIONAL
2017-04-13
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Post-operative Crohn Disease patients
Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
OTHER
Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Federica Furfaro, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1687
Identifier Type: -
Identifier Source: org_study_id
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