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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-13

Study Completion Date

2019-05-31

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

Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

OTHER

Sponsor Role collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federica Furfaro, MD, PhD

Role: CONTACT

+390282245555

Silvio Danese, MD, PhD

Role: CONTACT

+390282245555

Facility Contacts

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Federica Furfaro, MD PhD

Role: primary

+390282245555

Other Identifiers

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1687

Identifier Type: -

Identifier Source: org_study_id

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