lymphedema after groin lymphadenectomy in patients with vulvar cancer MedDRA version: 14.1 Level: LLT Classification code 10025233 Term: Lymphedema System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: TACHOSIL*1SPUGNA 9,5CMx4,8CM
Pharmaceutical Form: Medicated sponge
INN or Proposed INN: HUMAN FIBRINOGEN
CAS Number: 9001-32-5
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness Parameters: 1. proportion of patients with grade 2 and grade 3 lymphedema at the discharge, at 6 weeks and 6 months after the surgery; 2.developing of symptomatic or asymptomatic lymphoceles; 3. if lymphoceles drainage, quantity of dained fluid; 4. number of days with drains (the removal of drains is forecast when the drained liquid is < 50cc); 4.volume of drained fluid each day 5. developing of other complications related to lymph node dissection such as infections, haematomas and wound dehiscence. SAFETY EVALUATION:1.angiooedeme, burning and pain in the drug application point (inguinal careful inspection during the hospitalization and during the follow-up medical examinations);2. increase of body temperature (measured during all the hospitalization period, 3 times a day); 4. bronchospasm, shivers, burst of heat, headache, hypotension, lethargy, feeling sick, tachycardia, feeling of thoracic constriction, tingling, vomiting (evaluation of all these parameters in the period after the surgery to detect possible hyper sensibility reactions).;Timepoint(s) of evaluation of this end point: At the discharge, at 6 weeks and 6 months after the surgery: proportion of patients with grade 2/3 lymphedema; during the hospitalization, at 6 weeks, at 3 and 6 months after the surgery: developing of symptomatic or asymptomatic lymphoceles; if lymphoceles drainage, quantity of dained fluid, developing of other complications related to lymphnode dissection. During the hospitalization: number of days with drains, volume of drained fluid each day. SAFETY EVALUATION:angiooedeme, burning and pain in the drug application point: during the hospitalization and during the follow-up medical examinations; increase of body temperature: during all the hospitalization period, 3 times/day); evaluation of all complications in the period after the surgery to detect hypersensibility reactions | — |
Countries
Italy
Contacts
Public ContactU.O. Ostetricia e Ginecologia
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Outcome results
None listed