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

NCT03150238 | Unknown

• 1 other identifier: 1687
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate

  re-operation rate

  12 months

Secondary Outcomes (1)

• Ideation of a new score for the risk of re-operation in CD patients

  12 months

Other Outcomes (1)

• Wall sonographic thickness

  12 months

Study Arms (1)

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

Interventions

observation of prognostic factors for relapse 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

Post-operative Crohn Disease patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Italian Group for the study of Inflammatory Bowel Disease (IG-IBD): collaborator

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Federica Furfaro, MD, phD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Furfaro, MD, PhD

CONTACT

+390282245555; federica.furfaro@humanitas.it

Silvio Danese, MD, PhD

CONTACT

+390282245555; IBDclinicaltrias@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: April 13, 2017
• Primary Completion: January 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

IT (1)