Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building (POCD2017)

Istituto Clinico Humanitas

Status

Unknown

Conditions

Crohn Disease

Treatments

Other: observation of prognostic factors for relapse

Study type

Observational

Funder types

Other

Identifiers

NCT03150238

1687

Details and patient eligibility

About

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.

Full 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

Enrollment

220 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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