Clinical Research Directory

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

Sponsor: Karolinska Institutet

Summary

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 wound will not be counted as complications caused by the groin lymph-node procedure. The study will also compare operating time, blood loss, complications during surgery, conversion to another surgical approach, length of hospital stay, duration of drainage, number of lymph nodes removed, later treatment-related problems, symptoms of leg or groin lymphedema, quality of life, groin recurrence, recurrence-free survival, overall survival, and health-care costs. Participants will complete quality-of-life and lymphedema questionnaires before treatment and at specified times after treatment. Clinical follow-up will continue regularly through 24 months, and survival follow-up is planned through 60 months. An early safety and feasibility review will take place after the first 10 participants have entered the robotic surgery group. The study will stop if the median number of lymph nodes removed per groin in that group is fewer than six. Groin recurrences will be monitored throughout the study, and enrollment may be stopped if an unexpectedly high recurrence rate is observed.

Official title: SP-RAIL: The Morbidity and Safety of Single-port Robotic-assisted Inguinofemoral Lymphadenectomy in Vulvar Squamous Cell Carcinoma - a Randomized Controlled Phase II Trial

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