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

Skin Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224744
• Other study ID #: 05 DIVE 03
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: September 11, 2014
• Start date: November 2005
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Skin Neoplasms
• Vulvar Neoplasms

Intervention

Device:
• ultracision
Surgery by Ultracision
• classical lymphadenectomy
classical lymphadenectomy

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the decrease of post-operative morbidity.		2012	No
Secondary	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	No