DRKS00027334尚未招募Unknown
Prospective randomized multicenter trial of prevention of groin complications by insertion of internal inguino-peritoneal drains after radical inguinofemoral lymphonodectomy for advanced vulvar cancer.
niversitätsklinikum Augsburg0 个研究点目标入组 100 人开始时间: 2023年9月5日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •Age over 18 years
- •- Inguinal-nodal positive vulvar carcinoma confirmed by sentinel lymphonodectomy (also after pos. frozen section) or by punch biopsy with indication for radical inguinofemoral lymphonodectomy unilaterally or bilaterally
- •- Primary vulvar carcinoma with a stage T2(>4cm) Nx
- •- Karnofsky index >80% and/or ECOG 0-1
- •- No history of invasive vulvar malignancy
- •- Consent to adjuvant radiation if indicated postoperatively
排除标准
- •- History of other malignancy with need for systematic therapy or radiotherapy in the vulva or groin area
- •- Lack of compliance for groin compression (e.g., dementia)
- •- Adipositas permagna from BMI 35 kg/m2
研究者
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