The international journal of medical robotics + computer assisted surgery : MRCAS · 2025
Retroperitoneal Versus Transperitoneal Robot Assisted Partial Nephrectomy: A Prospective Controlled Non-Randomized Single Centre Study Non-Inferiority Design.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Mager Rene, Tsaur Igor, Höfner Thomas, Gheith Mohamed Kamal, Duwe Gregor, Haack Maximilian, Azar Jonathan, Aboulmaouahib Brahim, Ziewers Stefanie, Sparwasser Peter, Frey Lisa, Thomas Anita, Haferkamp Axel
Аннотация
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).
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).