Abstract
<title>Abstract</title> <p>Background After systematic inguinal lymphonodectomy, patients with vulvar cancer experience high postoperative morbidity due to inguinal seromas, lymphoceles, wound infections, and dehiscences. These complications often delay indicated adjuvant radiotherapy or require prolonged wound treatment. Studies have shown that internal inguino-peritoneal drains reduce the formation of lymphoceles by diverting lymph fluid from the lower limb into the peritoneal cavity. This prospective randomized multicenter trial aims to investigate whether inguino-peritoneal drainage can significantly reduce postoperative morbidity after systematic inguinofemoral lymphonodectomy in vulvar cancer patients. Methods This is a prospective randomized multicenter interventional trial with two study arms. Patients will be randomized intraoperatively to either standard volume-controlled drainage or inguino-peritoneal drainage after systematic inguinofemoral lymphonodectomy. The primary endpoint is the reduction of at least one postoperative complication (seromas, lymphoceles, wound healing disorders, infections, or drainage-related complications) of Clavien-Dindo grade III-a or higher within 3 months after primary surgery. Secondary endpoints include improvement in quality of life, reduction in time until initiation of adjuvant radiotherapy, and reduction of length of hospital stay. The calculated sample size is 100 patients (50 per arm) based on a two-sided Z-test with alpha = 0.05 and power of 80%, accounting for a 10% dropout rate. Discussion Internal inguino-peritoneal drainage represents a potentially effective method for reducing postoperative morbidity after systematic inguinofemoral lymphonodectomy. By diverting lymph fluid into the peritoneal cavity, the formation of seromas and lymphoceles may be prevented, potentially improving patient quality of life and enabling timely adjuvant therapy. The main risks include the need for a second operation to remove the drain, potential drain dislocation, and infection risk. This trial will provide evidence on the safety and efficacy of this intervention. Trial registration The study was registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) under registration number DRKS00027334 on September 5, 2023. Registry URL: https://drks.de/search/en/trial/DRKS00027334</p>