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Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

Study acronym: RIC-2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 26 entriesv3
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2025 to Oct 2027 · Start date changed from estimate of Mar 2025 to Sep 15, 2025 · Completion date: Mar 2027 to Mar 2028 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Oct 2025 to Oct 2027
    • Start date changed from estimate of Mar 2025 to Sep 15, 2025
    • Completion date: Mar 2027 to Mar 2028
    • Site details revised at 2 of 2 sites
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy. The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
Trial Details
NCT Number NCT06856044
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Crohn Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov