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

Официальное название

Etude Prospective Exploratoire Pilote de sécurité, d'Une Chirurgie Emportant le mésentère Chez Les Patients Porteurs d'Une Maladie de Crohn Avec Atteinte iléo-colique Sous biothérapie

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Post-surgical complication rate [Срок оценки: 30 days after surgery]

Вторичные конечные точки (12)

• Postoperative endoscopic recurrence [Срок оценки: 6 months]
• Surgical time of the ileocolic resection technique [Срок оценки: End of surgery]
• Intraoperative bleeding [Срок оценки: End of surgery]
• Length of hospital stay [Срок оценки: End of hospitalization (max 1 month)]
• Presence of intra- and post-operative complications [Срок оценки: Immediately following surgery]
• Number of intra- and post-operative complications [Срок оценки: Immediately following surgery]
• Time until resumption of transit following surgery [Срок оценки: Following surgery (maximum 5 days)]
• Time until resumption of eating [Срок оценки: Following surgery (average 1 day)]
• Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin [Срок оценки: Immediately following surgery]
• Number of lymph nodes in the histological specimen [Срок оценки: Immediately following surgery]
• Resection not in healthy margin [Срок оценки: Immediately following surgery]
• Length of resected digestive tract [Срок оценки: Immediately following surgery]

Критерии участия

Критерии включения

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• Patient with histologically proven Crohn's disease
• Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation)
• Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab)
• Patient able to understand, write and read French

Критерии исключения

• The patient is participating in an interventional study
• The patient is under safeguard of justice or state guardianship
• Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab
• Contraindication to surgery, such as major cardiovascular comorbidities
• Pregnant, breast-feeding or parturient women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHU de Montpellier Hôpital St Eloi — Montpellier
• CHU de Nîmes — Nîmes

Идентификаторы

NCT: NCT06856044 · NIMAO/2023-2/MB-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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