Post-Operative Crohn's Disease Outcome in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

Azathioprine: Children with Crohn's disease who are treated with azathioprine for post-operative prophylaxis following ileo-cecal resection

Anti-TNF Drug: Children with Crohn's disease who are treated with anti-TNF monotherapy for post-operative prophylaxis following ileo-cecal resection

Study summary

Objectives: To examine the effect of prophylaxis therapy on clinical and endoscopic disease recurrence in children with Crohn's Disease (CD) following ileo-cecal resection. Hypothesis: Post-operative pediatric patients treated with anti-Tumor necrosis factor (TNF) prophylaxis will demonstrate lower endoscopic recurrence rates at 1 year and lower clinical recurrence rates at 2 years compared with thiopurines treated patients. Design: A multi-center, prospective, observational study. Patients with either thiopurines or anti-TNF prophylaxis will be enrolled 0-6 months following ileo-cecal resection. Prophylactic treatment will be decided at the discretion of the treating physician and not as a part of the study. According to standard-of-care, patients will undergo a colonoscopic evaluation 6-9 month following surgery. Study visits will be performed at 6 months following resection, 12 months, 18 months and 24 months. Setting: Porto group and IBD interest group pediatric gastroenterology centers. Participants: Children 6 year to 18 years (Overall, 84 patients) with CD following limited ileo-cecal resection. Main outcome measure: 1. Endoscopic recurrence at 1 year (according to Rutgeerts Score: i2-i4). 2. Clinical recurrence at 2 years (according to pediatric Crohn's disease activity index-PCDAI: ≥10). Secondary outcome measures: 1. Re-operation rate at 2 years. 2. Exacerbation-free quartiles at 2 years. 3. Anthropometric and laboratory measures including calprotectin at each visit. 4. Changes in fecal microbiome- baseline, 1 year and 2 years. Inclusion criteria: 1. CD with phenotypes L1 and L3 following ileo-cecal resection. 2. No active perianal disease. 3. Prophylactic therapy with either thiopurines or anti-TNF. Exclusion criteria: 1. Pregnancy. 2. Active perianal disease (draining fistula or abscess). 3. Post-operative intra-abdominal complication (fistula or abscess). Sample size: In order to demonstrate 20% difference in endoscopic recurrence rate between groups is significant, we will need to study 42 children in each group to be able to reject the null hypothesis that the failure rates between the groups are equal with probability (power) of 80% and a type I error probability of 0.05.

Eligibility

Primary outcome measure(s)

• Endoscopic recurrence (Rutgeerts score ≥ i2b) — 12 months following resection
  According to Rutgeerts score The Rutgeerts score: i0-no lesions in the neoterminal ileum i1-fewer than 5 aphthous lesions in the neoterminal ileum i2a-lesions confined to the ileocolonic anastomosis, including anastomotic stenosis), i2b-more than 5 aphthous ulcers or larger lesions, with normal mucosa in between, in the neoterminal ileum, with or without anastomotic lesions i3-diffuse aphthous ileitis with diffusely inflamed mucosa i4-large ulcers with diffuse mucosal inflammation or nodules or stenosis in the neoterminal ileum.

Trial sites (1)

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