Not Signed In -
CPAP Device |
|
|
Clinical Trial: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
This study is not yet open for patient recruitment.
Verified by Institut Claudius Regaud September 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Vulvar Neoplasms Skin Neoplasms | Device: ultacision Device: classical lymphadenectomy | Phase III |
MedlinePlus related topics: Skin Cancer; Vulvar Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Further Study Details:
Primary Outcomes: To evaluate the decrease of post-operative morbidity.
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.
Expected Total Enrollment: 145
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.
Expected Total Enrollment: 145
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00224744
Denis Querleu, Pr +33.5.61.42.41.50 querleu@icr.fnclcc.fr
France
Institut Claudius Regaud, Toulouse, France
Denis Querleu, Pr +33.5.61.42.41.50 querleu@icr.fnclcc.fr
Pierre Martel, Dr, Sub-Investigator
Gwenael Ferron, Dr, Sub-Investigator
Pierre Martel, Dr, Sub-Investigator
Gwenael Ferron, Dr, Sub-Investigator
Institut Paoli-Calmettes, Marseille, France
Pr Gilles Houvenaeghel, Pr +33.4.91.22.35.32 houvenaeghel@marseille.fnclcc.fr
Study chairs or principal investigators
Denis Querleu, Pr, Principal Investigator, Institut Claudius Regaud
More Information
Study ID Numbers: 05 DIVE 03
Last Updated: September 22, 2005
Record first received: September 22, 2005
ClinicalTrials.gov Identifier: NCT00224744
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-27
Last Updated: September 22, 2005
Record first received: September 22, 2005
ClinicalTrials.gov Identifier: NCT00224744
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-27
email this page
print this page
bookmark this page
feedback on this page
