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

Crohn Disease Clinical Trial

— POCD2017  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150238
• Other study ID #: 1687
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2017
• Last updated: May 11, 2017
• Start date: April 13, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2017
• Source: Istituto Clinico Humanitas
• Contact: Federica Furfaro, MD, PhD
• Phone: +390282245555
• Email: federica.furfaro[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: May 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Italian Group for Inflammatory Bowel Diseases (IG-IBD)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wall sonographic thickness	Wall sonographic thickness will be measured, to define, if feasible, a precise cut-off of thickness that could predict the risk of re-intervention, by a correlation with Rutgeerts' score	12 months
Primary	Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate	re-operation rate	12 months
Secondary	Ideation of a new score for the risk of re-operation in CD patients	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.	12 months