NL-OMON53021招募中3 期
Mesenteric Sparing versus more extended mesenterectomy in Ileocolic Resection for ileocecal Crohn*s Disease - SPICY trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16 至 99（—）
入选标准
- •11) Males and females aged >16 years,
- •2) Ileo(colic) disease with an indication for primary ileocaecal - or ileocolic
- •3) All concurrent therapies are permitted,
- •4) All patients should have terminal ileitis (L1 or L3 disease), previously
- •confirmed during endoscopy, with a recent update (<= 3 months) of imaging (e.g.
- •ultrasound, MR, CT enterography) before confirmation eligibility, preferably
- •discussed in MDT,
- •5) ability to comply with protocol,
- •6) competent and able to provide written informed consent.
排除标准
- •1. Inability to give informed consent.
- •2. patients less than 16 years of age.
- •3. Patients undergoing repeated ileocolic resection.
- •4. 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.
- •5. History of cancer < 5 years which might influence patients prognosis
- •6. Emergent operation.
- •7. Pregnant or breast feeding.
- •8. Inability to follow up at 3, 6 and 12 months for postoperative assessment,
- •imaging and endoscopy.
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