Trial Information
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the decrease of post-operative morbidity.
Outcome Time Frame:
2012
Safety Issue:
No
Principal Investigator
Denis Querleu, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Claudius Regaud
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
05 DIVE 03
NCT ID:
NCT00224744
Start Date:
November 2005
Completion Date:
January 2013
Related Keywords:
- Vulvar Neoplasms
- Skin Neoplasms
- Vulvar Neoplasms
- Skin Neoplasms
- Ultracision
- Lymphadenectomy
- Neoplasms
- Skin Neoplasms
- Vulvar Neoplasms