Status:
RECRUITING
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Crohn Disease (CD)
Ileocolic Resection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Crohn's disease (CD) (\> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use o...
Detailed Description
This is a prospective, open-label, multicenter, two-arm, randomized, controlled clinical trial evaluating innovative versus standard care in patients with Crohn's disease. All eligible patients will b...
Eligibility Criteria
Inclusion
- Patients with an established diagnosis of CD according to ECCO guidelines
- Adult Crohn's disease (age ≥ 18 years)
- Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions
- With an anastomosis that can be reached by ileocolonoscopy
- With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel \> 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery
- No contraindication to ustekinumab treatment
- Patient capable of giving consent
- Patient covered by the French healthcare system
Exclusion
- Permanent stoma
- Total colectomy
- Uncontrolled postoperative infectious complication
- Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
- Refusal to participate in the study
- Persons deprived of their liberty by judicial or administrative decision
- Minors
- Vulnerable protected adults (under guardianship, curatorship, or legal protection)
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06972901
Start Date
October 13 2025
End Date
March 1 2027
Last Update
December 3 2025
Active Locations (8)
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1
CHU d'Amiens
Amiens, France
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France
3
CHU de Lille
Lille, France
4
HCL
Lyon, France