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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open . 2026 Mar 26;16(3):e110106. doi: 10.1136/bmjopen-2025-110106 Search in PMC Search in PubMed View in NLM Catalog Add to search Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study) Rianne E M Killaars Rianne E M Killaars 1 Department of Paediatric Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 3 Research Institute of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, The Netherlands Find articles by Rianne E M Killaars 1, 2, 3, ✉ , Ruben G J Visschers Ruben G J Visschers 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 4 Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Center+ (MUMC+), Maastricht, The Netherlands Find articles by Ruben G J Visschers 2, 4 , Hamit Cakir Hamit Cakir 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 4 Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Center+ (MUMC+), Maastricht, The Netherlands Find articles by Hamit Cakir 2, 4 , D J A Dinjens D J A Dinjens 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 4 Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Center+ (MUMC+), Maastricht, The Netherlands Find articles by D J A Dinjens 2, 4 , Daniel L Widmann Daniel L Widmann 5 Department of Paediatric Surgery, Dr. von Hauner Children’s Hospital, LMU University Hospital, Munich, Germany Find articles by Daniel L Widmann 5 , Holger Friedrich Holger Friedrich 6 Clinical Registry Coordinator Asensus, Meerbusch, Germany Find articles by Holger Friedrich 6 , Oliver Muensterer Oliver Muensterer 5 Department of Paediatric Surgery, Dr. von Hauner Children’s Hospital, LMU University Hospital, Munich, Germany Find articles by Oliver Muensterer 5 , Wim G van Gemert Wim G van Gemert 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 3 Research Institute of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, The Netherlands 4 Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Center+ (MUMC+), Maastricht, The Netherlands Find articles by Wim G van Gemert 2, 3, 4 , Jan Goedeke Jan Goedeke 5 Department of Paediatric Surgery, Dr. von Hauner Children’s Hospital, LMU University Hospital, Munich, Germany Find articles by Jan Goedeke 5 ; The MiniTrust Collaborative Study Group Author information Article notes Copyright and License information 1 Department of Paediatric Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands 2 European Consortium of Pediatric Surgery (Maastricht UMC+, Uniklinik Aachen, Clinique CHC MontLégia Liège), Maastricht, The Netherlands 3 Research Institute of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, The Netherlands 4 Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Center+ (MUMC+), Maastricht, The Netherlands 5 Department of Paediatric Surgery, Dr. von Hauner Children’s Hospital, LMU University Hospital, Munich, Germany 6 Clinical Registry Coordinator Asensus, Meerbusch, Germany ✉ Rianne E M Killaars; [email protected] None declared. Received 2025 Oct 3; Accepted 2026 Mar 2; Collection date 2026. Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13034209 PMID: 41887639 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 . Keywords: SURGERY, PAEDIATRIC SURGERY, Minimally invasive surgery, Child STRENGTHS AND LIMITATIONS OF THIS STUDY. The MiniTrust registry is explicitly designed to support staged Identify, Define, Explore, Act, Look (IDEAL) compliant evaluation, enabling early safety assessment, learning curve analysis, and future comparative and long-term outcome studies. The inclusion of both prospective and retrospective data enhances the comprehensiveness of the registry and supports the evaluation of outcomes even in small-volume cases. The multicentric design ensures inclusion of a large population and allows generalisability by accounting for variability in clinical practice and setting. Standardised use of validated classification systems (Clavien-Dindo classification) ensures consistent and comparable assessment of surgical outcomes and adverse events. Absence of a parallel control group, with conventional laparoscopic techniques, limits the ability to directly compare outcomes. Introduction Minimally invasive surgery (MIS) has revolutionised surgical practice by reducing patient trauma, accelerating recovery and minimising hospital stays. 1 2 Over the past decade, robotic-assisted surgery (RAS) has continued to emerge as a transformative approach, offering enhanced precision, dexterity and visualisation in confined anatomical spaces. 3 While these factors are relevant for adults, they might be especially advantageous in paediatric surgery. 4 5 The Senhance Surgical System (SSS; Asensus Surgical (Durham, NC, USA)) is a robotic platform designed to augment laparoscopic procedures through advanced features including 3D stable visualisation, motion scaling, tremor filtration and multiaxial instrument control. The system allows the use of 3 mm and 5 mm instruments, enabling minimally invasive approaches even in small paediatric patients. Its modular design offers flexibility in trocar placement and support in optimal ergonomics for cockpit surgeons. The SSS received US Food and Drug Administration clearance and holds CE certification since 2017. It was developed specifically for use in children, making it distinctly different from other platforms. The SSS is currently the only robotic platform offering 3 mm and 5 mm articulated instruments, a feature of particular importance in paediatric surgery and in the children of small body size, where trocar size and instrument diameter are critical limiting factors. This technical characteristic provides a strong rationale for system-specific evaluation within a dedicated registry. The growing body of clinical data supports the safety and feasibility of the SSS in paediatric surgery. 6 , 8 A post-market clinical follow-up (PMCF) study conducted between 2021 and 2023 at Maastricht University Medical Center+ demonstrated favourable outcomes in 42 paediatric patients undergoing abdominal surgery using the SSS and 3 mm or 5 mm instruments. 9 Additional case studies have documented the successful use of robotic pyeloplasty in a 1½-year-old child and highlighted the cost-effectiveness of the platform using reusable 3 mm instrumentation. 8 9 These benefits are further amplified by the ergonomic and optical enhancements of the system, which help overcome traditional limitations in paediatric laparoscopy, such as unstable camera guidance, rigid instruments and constrained working spaces. 9 10 Besides these encouraging results, relevant study data are currently lacking to a sufficient extent, mainly due to the low volume of paediatric robotic cases (especially in infants and small children) at individual centres. Therefore, a prospective (and retrospective) registry aims to collect real-world clinical data on the safety and performance of the SSS in a larger, more diverse paediatric patient population. This study aims to provide further evidence supporting the usefulness of the system in routine clinical practice for paediatric MIS. IDEAL framework and study rationale This registry is designed in accordance with the Identify, Define, Explore, Act, Look (IDEAL) framework for the evaluation of surgical innovation. 10 Robotic-assisted paediatric surgery using the SSS represents an evolving surgical technology for which systematic, staged evaluation is essential. The MiniTrust registry initially corresponds to IDEAL stage 1–2a (development and exploration), focusing on prospective documentation of procedural details, technical feasibility, safety outcomes and early performance metrics. Importantly, the registry is designed as a long-term, continuous data collection platform, allowing transition to IDEAL stage 2b (assessment) through comparative analyses with conventional laparoscopic or open procedures once sufficient case numbers are accrued, and ultimately to IDEAL stage 3, enabling evaluation of long-term outcomes and rare adverse events (AEs). This staged registry-based approach is particularly relevant in paediatric surgery, where procedure volumes are limited and randomised trials are often impractical. By prospectively capturing standardised data across multiple centres, the MiniTrust registry provides the infrastructure required for comprehensive IDEAL-compliant evaluation over time. Study aim and hypothesis Study aim This study aims to confirm the safety and performance of the SSS in paediatric patients undergoing RAS across a broad range of surgical indications. This will be achieved through the establishment of a prospective (and retrospective) registry study collecting real-world clinical data from a large paediatric population. Our primary objective is to evaluate the safety of the SSS by determining the rate of 30-day procedure-related AEs (Clavien-Dindo classification >grade III) and the proportion of procedurally related serious AEs (SAEs) within 3 months post-procedure. 11 12 As a secondary objective, we aim to assess the performance of the SSS through (a) duration of hospitalisation for the index procedure (ie, the patient’s surgical procedure that led to registry inclusion); (b) rate of unplanned conversion to open surgery due to the SSS; and (c) patient-reported outcomes, specifically pain perception scores. All endpoints will be benchmarked against existing literature on conventional paediatric laparoscopic surgery. Study hypothesis We hypothesise that the safety and performance of the SSS are equivalent to outcomes reported in the recent literature for comparable conventional laparoscopic procedures in a representative paediatric population. We further hypothesise that the routine use of the SSS in paediatric procedures provides additional clinical benefits, including reduced hospital stay and improved patient-reported pain outcomes, compared with conventional laparoscopy. Methods and analysis Study design and setting This registry is designed as a multicentric, observational, post-market clinical follow-up (PMCF) registry study, collecting both prospective and retrospective data on SSS application for paediatric procedures in urology, gynaecology and general surgery. It is conducted under real-world conditions without a parallel control group, aligning with post-market surveillance obligations under the European Union’s Medical Device Regulation (EU 2017/745) and ISO 14155:2020. The pilot phase of the registry will be conducted at two established European sites: the Dr von Hauner Children’s Hospital (University of Munich, Munich, Germany) and the MosaKids Children’s Hospital of Maastricht University Medical Center+ (Maastricht, the Netherlands). Additional study sites may be included as the registry progresses toward full-scale implementation. Its current version was issued on 25th June 2024 in V.1.0. Study population Screening and inclusion and exclusion criteria Patients are screened if they are eligible for MIS for their indication and will be informed of the ongoing registry. They will be introduced to the study’s aim and asked to provide consent to the registry (either by themselves and/or by a legal guardian, depending on the child’s age). Study site investigators may enter case data retrospectively without the obligation to obtain permission for its use in the registry. On explicit request and without the need for justification, patients can be withdrawn from the registry. Patients will be eligible for inclusion if they meet all of the following criteria: (a) aged <18 years; (b) body weight ≥10 kg; (c) indicated for robot-assisted laparoscopic surgery; (d) treated at one of the participating sites during the data collection period; (e) for prospective cases: provision of informed consent by the legal guardian or patient (if age-appropriate); and (f) anticipated survival of ≥3 months to enable follow-up assessments. Patients will be excluded if any of the following criteria apply: (a) requirement for cardiac or major vascular surgery; (b) unsuitability for laparoscopic or thoracoscopic access; (c) contraindications for anaesthesia or electrosurgery (eg, pacemakers); (d) malignancy or known cancer diagnosis; (e) pregnancy beyond the second trimester; (f) inability to understand and consent in understandable language in specific centre; (g) conditions contraindicating laparoscopic access based on clinical judgement; and (j) requirement for procedures involving the upper mediastinum or upper pleural cavity. Study timeline The first prospective patient was enrolled in the first quarter of 2025. The pilot registry phase will span 1 year and may include retrospective cases with index procedures performed prior to April 2025. Each subject will be followed up at 30 days and 3 months postoperatively. Pending feasibility and data quality outcomes, the pilot registry is intended to be extended into a long-term registry (with full-scale implementation) with an initial duration of up to 10 years, allowing for the evaluation of long-term trends and analysis of rare paediatric diseases. Participation timeline After screening, confirming eligibility and obtaining written informed consent, patients are enrolled in the registry, and their data are pseudonymised. At baseline, their demographic and medical history are collected, and on their index procedure, the surgical procedure is performed using the SSS. Perioperative data are collected, including various parameters such as operation time, console time, blood loss, device errors and unplanned conversions to open surgery. Additionally, postoperative pain management, length of hospital stay and wound status are documented during hospitalisation. Surgical complications and SAEs are assessed within the 3-month follow-up period, accompanied by physical follow-up appointments as part of standard post-procedural care. Individual participation concludes 3 months after the index procedure. Patient and public involvement Patients and the public were not involved in the design, conduct or reporting of this registry study. The MiniTrust registry collects data from routine paediatric surgical care, and no additional interventions or study procedures were introduced. Results of the study will be disseminated through peer-reviewed publications, presentations at scientific conferences and regulatory reports. Once sufficient data are available, summary results will be communicated in easy-to-understand language to participating families and relevant patient advocacy groups. Data and outcomes Outcome measures Primary outcome of the registry is safety, defined as the rate of procedure-related AEs classified as Clavien-Dindo >grade III 11 12 within 30 days, and the incidence of SAEs adjudicated as related to the procedure up to 3 months postoperatively. Secondary outcomes refer to procedure performance metrics, including the duration of hospitalisation, rate of unplanned conversion to open surgery due to limitations of the SSS and patient-reported outcomes assessed through pain perception scores. Data collection and management During the pilot phase, data will be collected using paper-based case report forms (CRFs). These CRFs will be compiled into patient binders, each containing (a) a cover sheet listing sponsor, clinical investigation plan version/date, CRF version and study title, and (b) individual CRFs marked with header/footer identifiers including site name, patient ID, CRF number and page number. An electronic data capture (EDC) system will be established before the initiation of the full-scale implementation. Data from the pilot phase will then be digitised and integrated into the database. User access will be role-based and granted only on completion of training. Investigators will be responsible for entering clinical data into the EDC, with monitors verifying data as outlined in the monitoring plan. Data protection and archiving All patient-related data will be managed in compliance with applicable data protection regulations. Paper CRFs will be stored in limited-access areas at the investigation sites. Each site will retain essential documents for a minimum of 15 years following study completion or discontinuation. Outcome measures and safety monitoring Clinical outcomes will be assessed perioperatively, during hospitalisation, and up until 3 months after the index procedure. The following key parameters will be documented perioperatively: operation time (min), console time (min), device errors encountered during the procedure, intraoperative parameters including pneumoperitoneum characteristics and estimated blood loss (mL), and unplanned conversion to open surgery with associated reasons. During hospitalisation, postoperative pain management (day 1 postoperative until discharge), patient-reported pain outcomes (with age-specific pain scoring systems) and application of the WHO analgesic ladder classification 13 are documented, as are the length of hospital stay and intensive care unit stay (if applicable, in days), and wound assessment (from day 2 postoperative until discharge). SAEs and AEs classified using the Clavien-Dindo classification, and their procedural relation and wound assessment are documented during the 3 month follow-up period. Clavien-Dindo classification The Clavien-Dindo classification 11 12 is used from grade I through V, increasing in severity to register and classify complications. This generally used classification makes the data suitable for comparison with other studies and data sets. Adverse events All AEs, adverse device effects (ADEs), SAEs and device deficiencies (DDs) will be continuously recorded from the time of informed consent until the end of follow-up. The following definition illustrates them: AEs represent any untoward medical occurrences in a subject, user or other person involved, regardless of relationship to the investigational device. SAEs include events resulting in death, life-threatening conditions, permanent damage, prolonged hospitalisation or congenital anomalies, among others. ADEs represent any AE associated with use of the device, including errors in use, malfunctions or issues related to labelling or instructions. Serious ADEs represent an ADE leading to outcomes classified as serious as above, and DD refers to any inadequacy in the identity, quality, safety or performance of the investigational device, including user errors or malfunctions. Documentation and reporting The principal investigator is responsible for the timely and accurate documentation of date of onset and resolution of AE/ADE, description and diagnostic workup, treatment administered, severity classification (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), moderate (minimal; local or non-invasive; limited intervention indicated), severe (medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling), life-threatening (urgent intervention indicated; disabling), fatal (death related to AE), causality assessment (unrelated; possibly related; probably related; causally related) to the device and/or procedure, and contributing factors (eg, underlying disease; other medical conditions; medications). All safety data will be reviewed. In cases of disagreement regarding causality or severity, opinions will be documented and reported. Any significant new findings or risk signals will be communicated promptly to the ethics committees and regulatory authorities. Procedures and surgical setup All procedures in this registry will be performed using the SSS. All sites have existing operating room (OR) infrastructure for the SSS and routinely use it for their paediatric procedures. System components The SSS is a multiport laparoscopic surgical system and comprises the following key components: (1) cockpit (where the cockpit surgeon’s control station is equipped with ergonomic seating), hand controls and an eye-tracking interface, enabling visualisation of the operative field and real-time control of the instruments and endoscope; (2) manipulator arms, which are independent robotic arms that translate commands from the cockpit to the surgical field, enabling fine motor control of instruments and endoscopes; and (3) node/intelligent surgical unit, which is the central processor that integrates inputs from the cockpit and transmits commands to the arms. It also processes and relays video signals to the 2D/3D monitor of the cockpit. Surgical instruments The following instruments will be used for the surgical procedures: (a) Senhance Passive and Monopolar Instruments for blunt and sharp dissection, ligation, suturing and tissue manipulation, and (b) Senhance Ultrasonic System, including generator, transducer and single-use dissector for precise soft tissue incisions and vessel sealing (up to 5–7 mm in diameter) with minimal thermal injury. All reusable components will be cleaned and sterilised prior to each use. The ultrasonic dissector is single-use and provided sterilely. Surgical technique Surgical procedures are performed via a multiport laparoscopic approach. The cockpit surgeon operates from the cockpit, using hand-operated controls with integrated force feedback to manipulate instruments. Visual input is provided through a high-definition 2D/3D monitor. The eye-tracking interface enables camera control, and a touchpad and keyboard allow for system navigation and instrument configuration. The SSS allows for various laparoscopic manoeuvres, including dissections (blunt and sharp), suturing (interrupted, continuous and circular), vessel and tubular structure preparation, as well as tissue grasping, retraction and ligation. Training requirements Only paediatric surgeons and OR staff trained and certified by Asensus Surgical are authorised to operate the SSS. This refers to surgeons with experience in RAS, scrubbed assistants familiar with robotic workflows, and circulating OR staff responsible for equipment setup and sterile field preparation. Learning curve At regular yearly intervals, the collected procedural data will be analysed to assess a learning curve, correlating the case volume of participating centres with procedural times. The latter is used as a surrogate parameter for team routine and competency. Monitoring plan and audits The present registry is monitored through respective audits to ensure the protection of rights, safety and well-being of patients, as well as the accuracy and completeness of reported data, and compliance with the protocol, regulatory requirements and ethics committee standards. Core monitoring activities include verifying source data, informed consent, timely electronic Code of Federal Regulations ((e)CRF) entries and reporting of AEs or DDs. Monitoring is conducted through site visits as outlined in a monitoring plan. Statistical analysis All enrolled subjects will be included in the complete analysis set, ensuring that the entire dataset is evaluated comprehensively. No formal sample size calculation has been conducted for this registry. The initial pilot phase aims to include approximately 50 prospective patients, based on the expected patient volume at participating sites. All eligible retrospective patients will be included. Subsequent phases of the registry may expand to include up to 1000 patients. A detailed statistical analysis plan (SAP) will be developed and finalised before the database lock for the final analysis. This plan outlines all analytical procedures and guides the interpretation of the study data. The SAP will include descriptive statistical methods to summarise outcome data. Categorical variables will be reported as frequencies and percentages. Continuous variables will be described using measures of central tendency and dispersion (mean, SD, median, IQR, minimum and maximum). AEs will be evaluated based on the Clavien-Dindo classification 11 12 and data from the initial 30 days post-index procedure period. SAEs and their relation to the procedure are assessed based on data collected over the 3-month period. Analyses will be stratified by procedure type, indication, participating centre and individual surgeon experience. Cumulative case numbers per surgeon will be recorded, allowing longitudinal assessment of learning curves, including trends in operative time, conversion rates and complication rates over time, in accordance with IDEAL stage 2a–b recommendations. All outcomes will be compared against published literature on comparable laparoscopic procedures, stratified by procedure type and indication (urology, gynaecology and general surgery). No imputation for missing data will be performed. If follow-up data are missing, this will be annotated as missing data. Ethics and dissemination Ethical considerations This registry-based clinical investigation adheres to the ethical principles outlined in the Declaration of Helsinki 14 and complies with Good Clinical Practice as per EN ISO 14155:2020, 15 the General Data Protection Regulation (GDPR) 16 and applicable national legislation. The study protocol, informed consent documents and all relevant materials were reviewed and approved by the responsible ethics committee(s) before any site initiation or subject enrolment. Approval was granted by the Ethics Committee of Maastricht (2024–0425) and by the Ethics Committee of Munich (2024–0589). Additionally, the study is registered with ClinicalTrials.gov ( NCT07081828 ). Only CE-marked medical devices used within their intended purpose are involved in this study. No additional invasive or burdensome procedures will be introduced outside of standard clinical care. The registry collects data on prospectively and retrospectively treated patients who meet the inclusion and exclusion criteria, using procedures that are already part of routine practice. Informed consent and vulnerable populations Informed consent will be obtained from all patients or their legal guardians prior to enrolment. Patients will be adequately informed both verbally and in writing regarding the nature, scope and purpose of the registry. Sufficient time will be provided to consider participation. For retrospective inclusion, explicit consent for the processing of personally identifiable data will be obtained where necessary, unless exemptions apply under local law. Special consideration is given to the inclusion of paediatric patients, a population classified as vulnerable under International Council for Harmonisation–Good Clinical Practice. Age-appropriate assent procedures and ethical safeguards will be applied. Data protection and confidentiality All data handling complies with GDPR 16 and site-specific standard operating procedures. Personal data will be pseudonymised, and access will be restricted to authorised personnel only. Data will be stored securely. No data will be used beyond the scope of the registry without additional consent. Changes to the protocol, including amendments and revisions, will require formal documentation, approval from the responsible investigator and, where applicable, notification to or re-approval by the ethics committee. Risk assessment No significant additional risks are associated with participation in this registry. The SSS is used in accordance with its CE-marked intended use, and all procedures are performed by qualified paediatric surgeons. Potential ADEs are mitigated through appropriate training, especially in adapting the system for paediatric use. While risks such as intraoperative bleeding are inherent to some surgical indications, these are managed according to standard clinical protocols. Participation in the registry does not increase these risks. All SAEs and AEs will be reviewed and adjudicated regarding their procedural relatedness. Study oversight and monitoring A safety committee will meet at regular intervals to evaluate safety data and study progress. Non-compliance with the protocol or GCP standards 15 may result in exclusion. In any case, standard patient care will continue unaffected, and enrolled patients will be followed up per protocol until their completion. Dissemination of results The results of this registry study will contribute to the understanding and future development of RAS in the paediatric population. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences, reports to regulatory bodies and stakeholders. Strengths and limitations The MiniTrust study represents one of the first dedicated registries designed to evaluate the safety and performance of RAS in the paediatric populations under real-world clinical conditions. A notable strength of this study is the inclusion of both prospective and retrospective data, which enhances the completeness of the dataset and facilitates outcome evaluation, even in low-volume procedures. Furthermore, the multicentric design enables the inclusion of a large and diverse patient population, thereby improving the generalisability of the findings by capturing variability in clinical practices and institutional settings. The use of standardised and validated classification systems, such as the Clavien-Dindo classification, 11 12 allows for consistent and comparable assessment of surgical outcomes and AEs across centres. Moreover, follow-up within 30 days and 3 months enables the detection of both early and intermediate-term complications, promising accurate judgement of outcomes with the SSS. However, a key limitation of the study is the absence of a parallel control group undergoing conventional laparoscopic procedures, which restricts the ability to make direct comparative analyses between surgical modalities. Finally, a particular limitation of the pilot trial is the lack of an electronic database, which makes data analysis more time-consuming and prone to human error. Discussion This MiniTrust registry aims to systematically collect real-world data on the use of the SSS in the paediatric populations undergoing RAS in urology, gynaecology and general surgery. This represents one of the first registries for robotic procedures in paediatric surgery, an investigational approach that has been under-represented in the literature to date. Collected data may help to contextualise procedure-related outcomes, particularly in terms of postoperative pain, hospital stay and enhancing surgical precision. Specifically, the registry will encompass parameters specific to RAS in children, such as trocar positions at different ages, body weight and proportions, 3 mm instruments and functionality of the eye-tracking camera. Focusing on a single robotic platform is a deliberate methodological choice. Given that the SSS uniquely enables robotic surgery in small children with 3 mm instruments, pooling different robotic platforms would compromise anatomical and technical comparability, particularly in infants and smaller children. A system-specific registry, therefore, aligns with IDEAL principles for early and exploratory phases of surgical innovation. By using a prospective and retrospective design without introducing additional risk or deviation from standard routine care, this registry enables a robust assessment of clinical safety and efficacy under real-world conditions in a multicentre heterogeneous population. Due to the low volume of many paediatric procedures, the MiniTrust registry facilitates the collection of robust data sufficient to draw meaningful conclusions that would otherwise be unattainable. However, the observational nature of the registry and the absence of a randomised control group limit the ability to directly compare outcomes with traditional laparoscopic surgery. Despite this, benchmarking against published literature may offer contextual understanding of the relative performance of SSS. In the long term, the MiniTrust registry is expected to provide structured, long-term data on the feasibility and safety of RAS in the paediatric populations, help refine best practices, and support the broader adoption of RAS in paediatric surgical care. As data accumulates across additional sites over 10 years, once the pilot phase is completed and the registry is rolled out to additional participants, it will also inform future clinical trials, training programmes and device enhancements. Footnotes Funding: This research was sponsored by Asensus Surgical (Durham, North Carolina, USA). The funder provided financial support for the registry and supplied the Senhance Surgical System used in the study. The funder had no role in study design, data collection, analysis, interpretation of data, manuscript writing or the decision to submit for publication. All authors had full access to the study data and took final responsibility for the decision to submit for publication. Prepublication history for this paper is available online. To view these files, please visit the journal online ( https://doi.org/10.1136/bmjopen-2025-110106 ). Patient consent for publication: Not applicable. Provenance and peer review: Not commissioned; externally peer reviewed. Collaborators: The MiniTrust Collaborative Study Group. Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. References 1. Jaffray B. Minimally invasive surgery. 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