The use of Tachosil as sealant in the prevention of lymphorrea after surgical removal of lymph nodes for vulvar cancer: a clinical controlled prospective trial
- Conditions
- lymphedema after groin lymphadenectomy in patients with vulvar cancerMedDRA version: 14.1Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-006059-13-IT
- Lead Sponsor
- A.O. UNIVERSITARIA INTEGRATA DI VERONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with histological diagnosis of vulvar cancer; - Stromal invasion > 1mm at the biopsy; - Performance status 0,1,2 o 3; - Platelets > 100000/mmc; - Creatinine <2 mg/dl; - Bilirubin <1.5 x normal value; - AST e ALT < 3 x normal value.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
- Previous Radio-Chemotherapy; - Pre-existing primary and secondary lower extremity lymphedema; - Superficial phlebitis or ulcer or lower extremity chronic infection; - Sealant excipients hypersensitivity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: reduction of grade 2 and grade 3 lymphedema incidence 3 months after the surgery in patients treated with TachoSil after groin Lymphadenectomy for vulvar cancer;Secondary Objective: reduction of other lymph node dissection complications (noticed at the discharge, at 3 months and 6 months) such as lymphorrea, wound dehiscence, infections, haematomas, symptomatic or asymptomatic lymphoceles, hospital discharge lymphedema and lymphedema 6 months after the surgery;Primary end point(s): proportion of patients with grade 2 and grade 3 lymphedema at the discharge, at 6 weeks and 6 months after the surgery;Timepoint(s) of evaluation of this end point: 3 months after surgery
- Secondary Outcome Measures
Name Time Method