Clinical trial NCT03150238: Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building
Official title: A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
First posted: 2017-05-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months

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

Eligibility criteria: 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

Primary outcomes:
measure: Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate
timeFrame: 12 months
Secondary outcomes:
measure: Ideation of a new score for the risk of re-operation in CD patients
timeFrame: 12 months
Other outcomes:
measure: Wall sonographic thickness
timeFrame: 12 months
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Federica Furfaro, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: