Evaluating post-operative outcomes in children with Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of prophylactic therapy on clinical and endoscopic disease recurrence in children diagnosed with Crohn's Disease after undergoing ileo-cecal resection. It will compare the outcomes of patients receiving anti-TNF therapy versus those treated with thiopurines, with evaluations occurring at multiple time points over two years. The study will enroll patients aged 6 to 17 who have recently undergone surgery and will follow standard care protocols for post-operative assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Crohn's disease
2. Age: 6 - 17 years (inclusive)
3. L1 or L3 phenotypes
4. Ileocecal resection in the previous 3 months
5. No active perianal disease (including draining fistula or a peri-anal abscess)
6. Prophylactic therapy with either thiopurines or anti-TNF has been initiated

Exclusion Criteria:

1. Pregnancy
2. Renal Failure
3. Current abscess or perforation of the bowel
4. Post-operative intra-abdominal complication (fistula or abscess)
5. Complicated or heavily draining perianal fistula (indolent non-draining or minimally draining fistula are not an exclusion criteria).
6. Previous malignancy
7. Sepsis or active bacterial infection
8. IBD unclassified

Where it's running

• Schneider Children's Hospital
  Petah Tikva, Israel, Israel Recruiting

Study contacts

• Principal investigator: Amit Assa, MD — Schneider Children's Medical Center, Israel
• Study coordinator: Amit Assa, MD
• Email: dr.amit.assa@gmail.com
• Phone: +972543522211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.