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


Phase 3
18 Years
N/A
Not Enrolling
Both
Vulvar Neoplasms, Skin Neoplasms

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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

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