NCT00224744已完成3 期
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- To evaluate the decrease of post-operative morbidity.
研究概览
简要总结
The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.
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
- 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
- •Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication.
- •Age ≥ 18 years
- •Hematological functions : leucocytes > 1500/mm3, hemoglobin > 8 g/dl, blood platelets > 150000/mm
- •Well informed written consent signed by the patient
- •Negative pregnancy test for female patient of child-bearing potential.
排除标准
- •Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted)
- •Massive lymph node invasion with femoro-vessels attack
- •Inclusion in another study (excepted study turned to inguinal lymph node)
- •Pregnant or nursing women
- •Patient under guardianship or trusteeship
研究组 & 干预措施
Classical surgical Inguinal curage
Active Comparator
Classical Inguinal curage
干预措施: classical lymphadenectomy (Device)
Ultracision surgical Inguinal curage
Experimental
干预措施: ultracision (Device)
结局指标
主要结局
To evaluate the decrease of post-operative morbidity.
时间窗: 2012
次要结局
- To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment.(2012)
研究者
研究点 (2)
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