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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Active

18 and over

Other

05 DIVE 03
NCT00224744

Trial Description

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.

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/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

Trial Contact Information

Trial Lead Organizations/Sponsors

Institut Claudius Regaud

Denis Querleu, Pr

Principal Investigator

Denis Querleu, Pr		Ph: +33.5.61.42.41.50
		Email: querleu@icr.fnclcc.fr

Trial Sites

France

Marseille

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Pr Gilles Houvenaeghel, Pr Ph: +33.4.91.22.35.32

Email: houvenaeghel@marseille.fnclcc.fr

Toulouse

Institut Claudius Regaud

Denis Querleu, Pr Ph: +33.5.61.42.41.50

Email: Querleu.Denis@claudiusregaud.fr

P. Martel Sub-Investigator

Gwenael Ferron, Dr Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00224744
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.