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

NCT00224744CompletedPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Institut Claudius Regaud

Enrollment

73

Start Date

2005-11-01

Completion Date

2013-01-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

ultracisionclassical lymphadenectomy

Conditions

Vulvar NeoplasmsSkin Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

To evaluate the decrease of post-operative morbidity.

Time frame: 2012

Secondary Outcomes

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.

Time frame: 2012

Locations

Institut Paoli-Calmettes, Marseille, France

Institut Claudius Regaud, Toulouse, France

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