Status:
COMPLETED
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Vulvar Neoplasms
Skin Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 rega...
Eligibility Criteria
Inclusion
- 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/mm3.
- Well informed written consent signed by the patient
- Negative pregnancy test for female patient of child-bearing potential.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00224744
Start Date
November 1 2005
End Date
January 1 2013
Last Update
September 12 2014
Active Locations (2)
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1
Institut Paoli-Calmettes
Marseille, France
2
Institut Claudius Regaud
Toulouse, France