Comparing surgical techniques for removal of the groin lymph nodes in the treatment of vulvar cancer

INTERVENTION: The inguinofemoral lymphadenectomy will be the standard procedure for both groins. For the intervention groin, the LigaSure device will be used to perform this surgical procedure and for the other groin, the conventional method (scalpel and/or electrocautery) will be used. The IFL will contain resection of superficial lymph nodes as well as deep femoral nodes. For the resection of inguinal lymph nodes, the fatty tissue beneath the subcutaneous tissue down to the fascia lata will be removed. The saphenous vein will be spared when possible. The femoral lymphadenectomy will be performed by splitting the fascia lata, and then resecting the node bearing fatty tissue medial to the femoral vessels within the opening of the fossa ovalis. The lateral part of the fascia lata will be spared and no Sartorius transposition will be performed. The wound will be closed in two layers and the skin will be closed with staples/stitches/intra cutaneous. Randomization process Patients were randomized to the intervention (LigaSure) for either the left or right groin. We used a variable block randomization method, with a block division of 2, 4 using Castor EDC. Follow‐up During the regular visits at the outpatient clinic two weeks after removal of the drains and eight weeks after surgery, the groins will be examined by a gynecologist or special wound care nurse and the incidence of any short term complication (wound breakdown and/or wound infection and/or lymphocele) will be assessed. All incidents and/or complications occurring within these 8 weeks will be documented. CONDITION: Vulval cancer ; Cancer ; Malignant neoplasm of vulva PRIMARY OUTCOME: The incidence of any short term complication (wound breakdown and/or wound infection and/or lymphocele) will be measured within 8 weeks after inguinofemoral lymphadenectomy. SECONDARY OUTCOME: ; 1. Surgeon experience using LigaSure will be measured using a questionnaire containing SURG‐TLX.; 2. Patient experience (including the maximum and minimum postoperative pain measured by a visual analogue score (VAS) and restriction of daily activities scored between 0 (no restrictions) and 10 (completely restricted)) will be measured using a questionnaire by telephone between 6 and 8 weeks after surgery.; 3. Operating time for inguinofemoral lymphadenectomy will be measured in minutes from incision to end of closure for each groin separately.; 4. The volume drained per day in mililitres per 24 hours per groin will be measured during the period when the drain is in situ.; 5. The duration of drainage in days.; 6. The duration of hospital stay in days.; 7. The frequency and duration of re‐admission during the follow‐up period of 8 weeks.; 8. The percentage of primary wound healing 8 weeks after inguinofemoral lymphadenectomy.; 9. The days wound care (number of days paid care is necessary) (intra‐ and extramural) is needed per groin during follow up.; 10. The need and nature of intervention following any short term complication per groin.; INCLUSION CRITERIA: 1. Female sex 2. Age = 18 years 3. Squamous cell carcinoma of the vulva with indication for bilateral inguinofemoral lymphadenectomy by separate groin incisions (also after SN procedure) 4. Able to visit the outpatient clinic