Virtual Interactive 3D Modeling to Improve Outcomes in Robot-Assisted Partial Nephrectomy: Clinical Trial Protocol for the Multicenter, Randomized 3DPN Study

虚拟交互式 3D 建模在改善机器人辅助部分肾切除术疗效中的应用:多中心随机 3DPN 研究的临床试验方案

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Abstract

3DPN is a prospective, multicenter, randomized, controlled, two-armed open trial with planned recruitment of 370 patients in ten centers over a period of 24 mo. The trial is evaluating the value of virtual interactive 3D modeling for robot-assisted partial nephrectomy (RAPN) by assessing clinical outcomes, patient understanding, and surgeon confidence. Patients aged ≥18 yr with kidney tumors ≤7 cm who have contrast-enhanced computed tomography (CT) scans available and for whom RAPN with a da Vinci Surgical System is planned are eligible for the study. Using 1:1 randomization, patients are assigned to either the 3D model-based RAPN arm or the 2D CT scan-based RAPN arm. This trial is registered on ClinicalTrials.gov as NCT06056505.

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