Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01).

The LAP-01 trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy.

To compare the functional and oncological outcomes between RARP and LRP at 3 mo of follow-up.

In this multicentre, randomised, patient-blinded controlled trial, patients referred for radical prostatectomy to four hospitals in Germany were randomly assigned (3:1) to undergo either RARP or LRP.

The primary outcome was time to continence recovery at 3 mo based on the patient's pad diary. Secondary outcomes included continence and potency as well as quality of life in addition to oncological outcomes for up to 3 yr of follow-up. Time to continence was analysed by log-rank test and depicted by the Kaplan-Meier method. Continuous measurements were analysed by means of linear mixed models.

A total of 782 patients were randomised. The primary endpoint was evaluable in 718 patients (547 RARPs; full analysis set). At 3 mo, the difference in continence rates was 8.7% in favour of RARP (54% vs 46%, p =  0.027). RARP remained superior to LRP even after adjustment for the randomisation stratum nerve sparing and age >65 yr (hazard ratio = 1.40 [1.09-1.81], p =  0.008). A significant benefit in early potency recovery was also identified, while similar oncological and morbidity outcomes were documented. It is a limitation that the influence of different anastomotic techniques was not investigated in this study.

RARP resulted in significantly better continence recovery at 3 mo.

In this randomised trial, we looked at the outcomes following radical prostate surgery in a large German population. We conclude that patients undergoing robotic prostatectomy had better continence than those undergoing laparoscopic surgery when assessed at 3 mo following surgery. Age and the nerve-sparing technique further affected continence restoration.

European urology. 2021 Feb 08 [Epub ahead of print]

Jens-Uwe Stolzenburg, Sigrun Holze, Petra Neuhaus, Iason Kyriazis, Hoang Minh Do, Anja Dietel, Michael C Truss, Corinn I Grzella, Dogu Teber, Markus Hohenfellner, Robert Rabenalt, Peter Albers, Meinhard Mende

Department of Urology, University of Leipzig, Leipzig, Germany. Electronic address: ., Department of Urology, University of Leipzig, Leipzig, Germany., Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany., Department of Urology, University of Leipzig, Leipzig, Germany; Department of Urology, University Hospital of Patras, Rio, Greece., Department of Urology, University of Leipzig, Leipzig, Germany; Department of Urology, Sana Hospital Borna, Borna, Germany., Department of Urology, Klinikum Dortmund, Dortmund, Germany., Department of Urology, University of Heidelberg, Heidelberg, Germany; Department of Urology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany., Department of Urology, University of Heidelberg, Heidelberg, Germany., Department of Urology, University of Duesseldorf, Duesseldorf, Germany; Department of Urology, Marien Hospital Duesseldorf, Duesseldorf, Germany., Department of Urology, University of Duesseldorf, Duesseldorf, Germany., Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany; Institute for Medical Informatics, Statistics and Epidemiology University of Leipzig, Leipzig, Germany.

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