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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Post-surgical complication rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patient with Crohn Disease
干预措施: ileocolic resection with extended mesenteric resection (Procedure)
结局指标
主要结局
Post-surgical complication rate
时间窗: 30 days after surgery
Percentage, graded according to the Clavien-Dindo Classification
次要结局
- Postoperative endoscopic recurrence(6 months)
- Surgical time of the ileocolic resection technique(End of surgery)
- Intraoperative bleeding(End of surgery)
- Length of hospital stay(End of hospitalization (max 1 month))
- Presence of intra- and post-operative complications(Immediately following surgery)
- Number of intra- and post-operative complications(Immediately following surgery)
- Time until resumption of transit following surgery(Following surgery (maximum 5 days))
- Time until resumption of eating(Following surgery (average 1 day))
- Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin(Immediately following surgery)
- Number of lymph nodes in the histological specimen(Immediately following surgery)
- Resection not in healthy margin(Immediately following surgery)
- Length of resected digestive tract(Immediately following surgery)
- Area of mesentery removed(Immediately following surgery)
- C-reactive protein level(Month 6)
- Albuminemia(Day before surgery)
- Hemoglobinemia(Day 4)
- White blood cells(Day 4)
- C-reactive protein level(Day 2)
- C-reactive protein level(Day 4)
- C-reactive protein level(Month 1)
- C-reactive protein level(Day before surgery)
- Hemoglobinemia(Day before surgery)
- Hemoglobinemia(Day 2)
- White blood cells(Day before surgery)
- White blood cells(Day 2)
- Fecal calprotectin(Month 3)