vulvar squamous cell carcinoma vuvlar cancer
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Female sex; - Age * 18 years; - Squamous cell carcinoma of the vulva with indication for bilateral inguinofemoral lymphadenectomy by separate groin incisions (also after SN procedure); - Able to visit the outpatient clinic; - Signed informed consent
Exclusion criteria
Exclusion criteria: - Patient not willing to sign and/or return the informed consent form; - Previous radiotherapy to vulva, groins and/or pelvis; - Previous pelvic lymphadenectomy; - Any histology other than squamous cell carcinoma; - Patient with indication for inguinofemoral lymphadenectomy with *en bloc* approach.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The differences in the incidence of short term complications (wound infection, wound breakdown and lymphocele) after IFL using LigaSure versus the conventional method. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are; * To determine the surgeon* experience using LigaSure * To determine the operating time for inguinofemoral lymphadenectomy * To determine the volume drained per day during the period when the drain is in situ * To determine the duration of drainage in days * To determine the duration of hospital stay * To determine the frequency and duration of re-admission during the follow-up period of 8 weeks; * To determine the percentage of primary wound healing 8 weeks after inguinofemoral lymphadenectomy; * To assess the days wound care (number of days paid care is necessary) (intra- and extramural) needed per groin during follow up; * To assess the need and nature of intervention following any short term complication | — |
Countries
Netherlands
Outcome results
None listed