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

NCT00224744 | Completed Phase 3

• 1 other identifier: 05 DIVE 03
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Vulvar Neoplasms; Skin Neoplasms

Keywords

Vulvar Neoplasms; Skin Neoplasms; Ultracision; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• To evaluate the decrease of post-operative morbidity.

  2012

Secondary Outcomes (1)

• 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

Study Arms (2)

Classical surgical Inguinal curage

ACTIVE COMPARATOR

Classical Inguinal curage

Device: classical lymphadenectomy

Ultracision surgical Inguinal curage

EXPERIMENTAL

Device: ultracision

Interventions

ultracision DEVICE

Surgery by Ultracision

Ultracision surgical Inguinal curage

classical lymphadenectomy DEVICE

classical lymphadenectomy

Classical surgical Inguinal curage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted)
• Massive lymph node invasion with femoro-vessels attack
• Pregnant or nursing women
• Patient under guardianship or trusteeship

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (2)

Institut Paoli-Calmettes

Marseille, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Denis Querleu, Pr

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 23, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2013-06

Locations

FR (2)