Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a...

Minimally invasive surgery (MIS) has improved patient outcomes by reducing surgical trauma and recovery times. Robotic-assisted surgery (RAS) advances MIS with superior precision, visualisation and ergonomics. These advantages are especially critical in paediatric procedures. The Senhance Surgical System (SSS) is a CE-marked robotic platform that enables RAS in children using 3 mm and 5 mm instruments. While RAS is routinely established in many adult procedures, its adoption and documentation in paediatric surgery are lagging. To address this disparity, the MiniTrust registry will generate real-world evidence on the safety and performance of the SSS in paediatric procedures.

This multicentre, observational post-market clinical follow-up (PMCF) registry study includes both prospective and retrospective cases of paediatric patients undergoing RAS in urology, gynaecology or general surgery. If the underlying diagnosis is suitable for treatment with RAS, patients under 18 years of age and weighing ≥10 kg are eligible. Primary outcomes include procedure-related adverse events (AEs) classified as Clavien-Dindo >grade III within 30 days, and serious AEs within 3 months. Secondary endpoints include length of hospital stay, unplanned conversion rates and patient-reported pain outcomes. Data are collected via standardised case report forms and analysed descriptively, with results benchmarked against conventional paediatric laparoscopy literature.

This study was approved in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Maastricht (2024-0425) and by the Ethics Committee of Munich (2024-0589). Results will be disseminated through peer-reviewed publications, scientific conferences and regulatory reports. This registry will contribute essential evidence to support the broader integration of RAS into paediatric surgical care.

NCT07081828.