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
{"title":"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","authors":"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","doi":"10.1002/rcs.70077","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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 (<i>p</i> = 0.6).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>The study was registered in the German Clinical Trials Register (DRKS00028619).</p>\n </section>\n </div>","PeriodicalId":50311,"journal":{"name":"International Journal of Medical Robotics and Computer Assisted Surgery","volume":"21 3","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/rcs.70077","citationCount":"0","resultStr":"{\"title\":\"Retroperitoneal Versus Transperitoneal Robot Assisted Partial Nephrectomy: A Prospective Controlled Non-Randomized Single Centre Study Non-Inferiority Design\",\"authors\":\"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\",\"doi\":\"10.1002/rcs.70077\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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 (<i>p</i> = 0.6).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>The study was registered in the German Clinical Trials Register (DRKS00028619).</p>\\n </section>\\n </div>\",\"PeriodicalId\":50311,\"journal\":{\"name\":\"International Journal of Medical Robotics and Computer Assisted Surgery\",\"volume\":\"21 3\",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-05-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/rcs.70077\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Medical Robotics and Computer Assisted Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/rcs.70077\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Medical Robotics and Computer Assisted Surgery","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/rcs.70077","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Retroperitoneal Versus Transperitoneal Robot Assisted Partial Nephrectomy: A Prospective Controlled Non-Randomized Single Centre Study Non-Inferiority Design
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).
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.
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