Peer-reviewed article
Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study).
Killaars REM, Visschers RGJ, Cakir H, Dinjens DJA, Widmann DL et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol paper describing the planned design of a registry study to evaluate robotic-assisted surgical systems in pediatric procedures. It outlines methods for collecting safety and performance data from children undergoing minimally invasive robotic surgery in urology, gynecology, and general surgery across multiple centers. The study will track adverse events, hospital stay length, conversion rates, and pain outcomes in children aged under 18 years.
Key points
- The MiniTrust registry is a multicenter observational study of robotic-assisted surgery (Senhance Surgical System) in children using 3mm and 5mm instruments
- Primary outcomes are procedure-related adverse events (Clavien-Dindo >grade III) within 30 days and serious adverse events within 3 months
- Secondary outcomes include length of hospital stay, unplanned conversion rates, and patient-reported pain
- Study includes prospective and retrospective cases of patients under 18 years weighing ≥10 kg
- Results will be benchmarked against conventional pediatric laparoscopy literature
Limitations
This is a protocol document, not a completed study, so no actual results or evidence of effectiveness are presented. The document describes planned methods only and cannot demonstrate whether the intervention improves child health outcomes.
Abstract
Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number NCT07081828.