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Surgical mapping with advanced 3D-reconstruction in minimally invasive liver surgery (SMART-MILS): protocol for a prospective randomised controlled trial

Por: Laurenz · N. · Bilge · A. · DeTemple · D. · van der Veen · J. · Tessmer · P. · Wiemann · B. A. · Oldhafer · F. · von Websky · M. · Vogel · T. · Vondran · F. W. · Beetz · O.
Introduction

Liver resection is a technically demanding procedure due to the complex and highly variable anatomy of the liver. Conventional preoperative planning relies on two-dimensional imaging, which requires mental reconstruction of three-dimensional anatomical relationships and may increase cognitive workload and intraoperative decision-making time. Patient-specific three-dimensional (3D) liver mapping has been shown to improve anatomical understanding and planning accuracy; however its impact on intraoperative efficiency has not been adequately investigated.

Methods and analysis

This is a prospective, randomised, controlled, open-label superiority trial with a 1:1 allocation ratio, stratified by planned resection type (extent of resection according to highest applicable Iwate difficulty score). Adult patients (≥18 years) scheduled for elective minimally invasive liver resection at the University Hospital RWTH Aachen will be enrolled. The control arm will receive standard preoperative planning using conventional two-dimensional CT and/or MRI. The intervention arm will receive additional patient-specific 3D liver mapping generated using CE-approved software (MeVis Liver Suite), available preoperatively and intraoperatively. The primary endpoint will be the operative time (minutes from the first cutaneous incision to the final suture). Secondary endpoints will include intraoperative blood loss, rate of R0 resection in oncological cases, length of stay in the hospital and intensive care unit, surgeon task load, surgeons’ salivary cortisol levels and cost-effectiveness. A total of 126 patients (63 per arm) will be enrolled to achieve 120 evaluable datasets.

Ethics and dissemination

Ethics approval has been obtained from the Ethics Committee of the Medical Faculty, University Hospital RWTH Aachen (Ref. No. 26–050). Written informed consent will be obtained from all patients and participating surgeons. Results will be disseminated through peer-reviewed publications and scientific conferences, independent of study outcomes.

Trial registration number

DRKS00039587.

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