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

Condition(s) studied

Investigational drug(s) / intervention(s)

ileocolic resection with extended mesenteric resection: The resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Post-surgical complication rate — 30 days after surgery
  Percentage, graded according to the Clavien-Dindo Classification

Trial sites (2)

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