About this trial
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 of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): \> 40% and \> 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to \> 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Permanent stoma
Total colectomy
Uncontrolled postoperative infectious complication
Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
Trial design
Parallel
Treatments tested in this trial
Early faecal calprotectin dosage
Biological/VaccineAn early dosage of faecal calprotectin will be done for the active arm group.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative endoscopic recurrence
Postoperative endoscopic recurrence at 6 months, defined by a Rutgeerts index ≥ i2. This primary endpoint will be defined by endoscopic procedure at 6 months postoperatively.
Sponsors and contacts
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