Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
研究概览
简要总结
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
详细描述
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
There is no blinding to the treatment allocation for the treating surgeon. The treatment will be blinded for the treating gastroenterologist, the endoscopist and the participants.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Ileocolic disease with an indication for ileocecal resection
- •Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
- •All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- •Ability to comply with protocol.
- •Competent and able to provide written informed consent.
- •Patient must have been discussed in the local MDT
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Inability to give informed consent.
- •patients less than 16 years of age.
- •Patients undergoing repeated ileocolic resection.
- •Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- •History of cancer < 5 years which might influence patients prognosis
- •Emergent operation.
- •Pregnant or breast feeding.
- •Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
结局指标
主要结局
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
时间窗: 6 months after surgery
次要结局
- Postoperative morbidity(30 days after surgery)
- Clinical recurrence rate following ileocolic resection(1 year after surgery)
- The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence(1 year after surgery)
- The 5 year reoperation rate for recurrence of disease at the anastomotic site.(5 years)
研究者
Willem A. Bemelman
Full professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)