Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to prevent the return of Crohn's disease symptoms after surgery, specifically focusing on patients who have had part of their intestines removed (ileocolic resection). Crohn's disease is a long-term illness that causes inflammation in the digestive tract, and even after surgery, many patients still experience symptoms or complications. The researchers believe that by measuring a substance called fecal calprotectin—a marker that indicates inflammation in the intestines—earlier after surgery, they can start treatment sooner if necessary. This could help reduce the chances of patients experiencing a return of symptoms or complications within the first six months after surgery.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of Crohn's disease who have recently undergone surgery without any visible remaining issues in the intestines. They should also have certain risk factors that could lead to a recurrence of symptoms, such as a history of smoking or previous surgeries. Participants in the trial will receive close monitoring and may start treatment earlier based on their fecal calprotectin levels. This study aims to find a better way to manage Crohn's disease after surgery, and it is currently not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)