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临床试验/NCT00224744
NCT00224744已完成3 期

Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.

Institut Claudius Regaud2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2005年11月最近更新:
适应症

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

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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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