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

Institut Claudius Regaud2 sites in 1 country73 target enrollmentNovember 2005

ConditionsVulvar Neoplasms Skin Neoplasms

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Vulvar Neoplasms
Sponsor: Institut Claudius Regaud
Enrollment: 73
Locations: 2
Primary Endpoint: To evaluate the decrease of post-operative morbidity.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 regard to classical operative techniques.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut Claudius Regaud

Responsible Party

Sponsor

Eligibility Criteria

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/mm
•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

Outcomes

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.(2012)