Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | 18 and over | Other | 05 DIVE 03 NCT00224744 |
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 Lead Organizations/Sponsors
Institut Claudius Regaud
| Denis Querleu, Pr |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00224744
Information obtained from ClinicalTrials.gov on June 03, 2013
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
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be directed to ClinicalTrials.gov.
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