PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Rate of endoscopic CD recurrence
研究概览
简要总结
Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence.
The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence.
Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease).
Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled.
- •Informed consent
排除标准
- •Crohn's Disease with a different localisation
- •Recurrent disease
- •Extensive jejunitis
- •<18 years of age
- •Cancer as primary indication for surgery
- •Followed by gastroenterologists outside our centre, due to loss of follow up
- •Ileostomy. If a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported
结局指标
主要结局
Rate of endoscopic CD recurrence
时间窗: 12 months
Endoscopic Rutgeerts score \>1
次要结局
- Rate of overall postoperative complications(30 days)
- Rate of major postoperative complications(30 days)
- Overall and Disease specific Quality of life(12 months)
研究者
Giuseppe Sigismondo Sica
Associate Professor, Head of Department
University of Rome Tor Vergata