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

A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Other: observation of prognostic factors for relapse

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

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Federica Furfaro, MD, PhD; Phone Number: +390282245555; Email: federica.furfaro@humanitas.it
• Study Contact Backup: Name: Silvio Danese, MD, PhD; Phone Number: +390282245555; Email: IBDclinicaltrias@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
      • Contact: Federica Furfaro, MD PhD; Phone Number: +390282245555; Email: federica.furfaro@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-operative Crohn Disease patients; Adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate	re-operation rate	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
• Investigators: Principal Investigator: Federica Furfaro, MD, phD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 1687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: TO BE DETERMINED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No