Long-term Outcome After Radical Lymph Node Dissection of Malignant Melanoma. Comparison Between Regional Versus General Anesthesia With Respect to Impact of Perioperative Immunoediting and Validation of New Potential Predictive Biomarkers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.
The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.
详细描述
Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.
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
- Single (Outcomes Assessor)
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
- •Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
- •Signed informed consent
排除标准
- •Age < 18 years
- •Female patients who are pregnant or nursing
- •Multiple organ failure
- •Contraindications
研究组 & 干预措施
Regional anesthesia
干预措施: Spinal anesthesia with Bupivacaine hyperbar 0.5 % (Procedure)
General anesthesia
干预措施: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane (Procedure)
结局指标
主要结局
Overall survival
时间窗: five years
次要结局
- Potential predictive biomarkers(Five days postoperatively)
- Changes of the total amount of immune cells(Five days postoperatively)
- Potential predictive biomarkers(24 hours postoperatively)
- Changes of the total amount of immune cells(15 minutes before end of surgery)
- Changes of the total amount of immune cells(24 hours postoperatively)
- Potential predictive biomarkers(15 minutes before end of surgery)