Retroperitoneal Versus Transperitoneal Robot Assisted Partial Nephrectomy: A Prospective Controlled Non-Randomized Single Centre Study Non-Inferiority Design

IF 2.3 3区医学 Q2 SURGERY

International Journal of Medical Robotics and Computer Assisted Surgery Pub Date : 2025-05-27 DOI:10.1002/rcs.70077

Rene Mager, Igor Tsaur, Thomas Höfner, Mohamed Kamal Gheith, Gregor Duwe, Maximilian Haack, Jonathan Azar, Brahim Aboulmaouahib, Stefanie Ziewers, Peter Sparwasser, Lisa Frey, Anita Thomas, Axel Haferkamp

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引用次数: 0

Abstract

Background

The value of the retroperitoneal (R-RAPN) compared with the conventional transperitoneal (T-RAPN) approach in robot-assisted partial nephrectomy has not been finally clarified. The current work's objective was to prospectively investigate R-RAPN versus T-RAPN.

Methods

The study was designed as a prospective, controlled, non-randomized study with a non-inferiority design. The primary endpoint was Trifecta achievement. The sample size calculation required 141 T-RAPN and 94 R-RAPN.

Results

When the recruitment target of 141 was reached in the T-RAPN arm, only 34 R-RAPN had been performed, so the study was terminated early. Trifecta as the main outcome parameter was achieved in 82% of the R-RAPN and 76% of the T-RAPN groups, so no sign for inferiority could be detected (p = 0.6).

Conclusions

In this prospective study, there was no evidence of inferiority of R-RAPN compared to T-RAPN for the Trifecta endpoint. R-RAPN may be an individually advantageous alternative to T-RAPN for selected patients.

Trial Registration

The study was registered in the German Clinical Trials Register (DRKS00028619).

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后腹膜与经腹膜机器人辅助部分肾切除术：一项前瞻性对照非随机单中心研究非劣效设计

背景在机器人辅助部分肾切除术中，腹膜后（R-RAPN）入路与常规经腹膜（T-RAPN）入路的比较价值尚未最终明确。目前的工作目的是前瞻性地研究R-RAPN与T-RAPN。方法采用前瞻性、对照、非随机、非劣效性设计。主要终点是triecta的疗效。样本量计算需要141个T-RAPN和94个R-RAPN。结果当T-RAPN组达到141个募集目标时，仅进行了34个R-RAPN，因此研究提前终止。trecta作为主要结局参数在82%的R-RAPN组和76%的T-RAPN组中实现，因此没有检测到劣效性的迹象（p = 0.6）。结论：在这项前瞻性研究中，没有证据表明R-RAPN与T-RAPN相比在Trifecta终点具有劣势。对于特定的患者，R-RAPN可能是T-RAPN的一种有利的替代方案。该研究已在德国临床试验注册中心（DRKS00028619）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Medical Robotics and Computer Assisted Surgery 医学-外科

CiteScore

4.50

自引率

12.00%

发文量

131

审稿时长

6-12 weeks

期刊介绍： The International Journal of Medical Robotics and Computer Assisted Surgery provides a cross-disciplinary platform for presenting the latest developments in robotics and computer assisted technologies for medical applications. The journal publishes cutting-edge papers and expert reviews, complemented by commentaries, correspondence and conference highlights that stimulate discussion and exchange of ideas. Areas of interest include robotic surgery aids and systems, operative planning tools, medical imaging and visualisation, simulation and navigation, virtual reality, intuitive command and control systems, haptics and sensor technologies. In addition to research and surgical planning studies, the journal welcomes papers detailing clinical trials and applications of computer-assisted workflows and robotic systems in neurosurgery, urology, paediatric, orthopaedic, craniofacial, cardiovascular, thoraco-abdominal, musculoskeletal and visceral surgery. Articles providing critical analysis of clinical trials, assessment of the benefits and risks of the application of these technologies, commenting on ease of use, or addressing surgical education and training issues are also encouraged. The journal aims to foster a community that encompasses medical practitioners, researchers, and engineers and computer scientists developing robotic systems and computational tools in academic and commercial environments, with the intention of promoting and developing these exciting areas of medical technology.