Comparative Trial Between Open and Single-port Robotic-assisted Groin Lymphadenectomy in Vulvar Cancer

In the researchers' words

Vulvar squamous cell carcinoma is a rare cancer that is usually treated with surgery. Some patients need removal of lymph nodes from one or both groins, called inguinofemoral lymphadenectomy. The standard open operation can cause wound infections, wound separation, fluid collections, prolonged drainage, and swelling of the leg. These complications are especially important because many people with vulvar cancer are older and may have other health conditions. SP-RAIL is an international, multicenter, randomized phase 2 study comparing two surgical approaches to inguinofemoral lymphadenectomy. The study plans to enroll 64 adults with a new diagnosis of vulvar squamous cell carcinoma who require this lymph-node surgery. Participants will be assigned by chance in a 1:1 ratio to either single-port robot-assisted inguinofemoral lymphadenectomy or traditional open inguinofemoral lymphadenectomy. Both groups will receive lymph-node removal according to the same anatomical boundaries. Sentinel lymph-node mapping or biopsy may also be performed as described in the protocol. The main question is whether the single-port robotic approach reduces clinically important complications during the first 30 days after surgery. Complications will be graded using the Clavien-Dindo classification, and grades 2 to 5 will be included in the primary outcome. Reoperations for separation of the vulvar…