C51
Conditions
Interventions
Group 1: inguino-peritoneal drain
Group 2: volume-controlled drain
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age over 18 years - Inguinal-nodal positive vulvar carcinoma confirmed by sentinel lymphonodectomy (also after pos. frozen section) or by punch biopsy with indication for radical inguinofemoral lymphonodectomy unilaterally or bilaterally - Primary vulvar carcinoma with a stage T2(>4cm) Nx - Karnofsky index >80% and/or ECOG 0-1 - No history of invasive vulvar malignancy - Consent to adjuvant radiation if indicated postoperatively
Exclusion criteria
Exclusion criteria: - History of other malignancy with need for systematic therapy or radiotherapy in the vulva or groin area - Lack of compliance for groin compression (e.g., dementia) - Adipositas permagna from BMI 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the incidence of at least one postoperative complication such as seromas, lymphoceles, wound healing disorders, infections, or complications from drainage of severity greater than or equal to Clavien Dindo grade IIIa within 3 months after primary surgery. between patients with inguino-peritoneal drainage and volume-controlled drainage. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement in quality of life - Shortening of time to start of adjuvant radiotherapy indicated by nodal status. - Shortening the length of hospital stay - Reduction in the need for physician visits - well tolerated pain - no change in progression free survival. | — |
Countries
Germany
Contacts
Public ContactCarl Mathis Wild
Universitätsklinikum Augsburg
Outcome results
None listed