Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)

What this Trial Is About

This research investigates the effectiveness of a robot-assisted laparoscopic approach to decompress the pudendal and inferior cluneal nerves in patients with entrapment neuralgias causing chronic pelvic perineal pain. It aims to assess how this surgical technique impacts pain, anxiety, depression, post-traumatic stress syndrome, and quality of life over a one-year follow-up period. The study focuses on those who have not found relief through medical treatments. The treatment involves a minimally invasive, robot-assisted laparoscopic decompression targeting both the pudendal and inferior cluneal nerves using a four-step surgical technique. This approach was developed to offer an alternative to the more invasive open trans-gluteal decompression, which requires longer recovery. The study monitors patients before surgery and at 2 days, 4 months, and 1 year after the procedure. Participants will undergo evaluations of pain using a composite criteria including numeric pain scales, time seated, and patient global impression of change (PGIC) scores at multiple time points. Researchers will also assess anxiety, depression, post-traumatic stress syndrome, and quality of life throughout the follow-up. Complications will be recorded during the same intervals to monitor safety and outcomes over the year-long observation.

Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study