Jens-Uwe Stolzenburg1, Sigrun Holze2, Petra Neuhaus3, Iason Kyriazis4, Hoang Minh Do5, Anja Dietel2, Michael C Truss6, Corinn I Grzella6, Dogu Teber7, Markus Hohenfellner8, Robert Rabenalt9, Peter Albers10, Meinhard Mende11. 1. Department of Urology, University of Leipzig, Leipzig, Germany. Electronic address: Jens-Uwe.Stolzenburg@medizin.uni-leipzig.de. 2. Department of Urology, University of Leipzig, Leipzig, Germany. 3. Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany. 4. Department of Urology, University of Leipzig, Leipzig, Germany; Department of Urology, University Hospital of Patras, Rio, Greece. 5. Department of Urology, University of Leipzig, Leipzig, Germany; Department of Urology, Sana Hospital Borna, Borna, Germany. 6. Department of Urology, Klinikum Dortmund, Dortmund, Germany. 7. Department of Urology, University of Heidelberg, Heidelberg, Germany; Department of Urology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany. 8. Department of Urology, University of Heidelberg, Heidelberg, Germany. 9. Department of Urology, University of Duesseldorf, Duesseldorf, Germany; Department of Urology, Marien Hospital Duesseldorf, Duesseldorf, Germany. 10. Department of Urology, University of Duesseldorf, Duesseldorf, Germany. 11. Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany; Institute for Medical Informatics, Statistics and Epidemiology University of Leipzig, Leipzig, Germany.
Abstract
BACKGROUND: The LAP-01 trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy. OBJECTIVE: To compare the functional and oncological outcomes between RARP and LRP at 3 mo of follow-up. DESIGN, SETTING, AND PARTICIPANTS: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: RARP resulted in significantly better continence recovery at 3 mo. PATIENT SUMMARY: 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.
BACKGROUND: The LAP-01 trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy. OBJECTIVE: To compare the functional and oncological outcomes between RARP and LRP at 3 mo of follow-up. DESIGN, SETTING, AND PARTICIPANTS: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: RARP resulted in significantly better continence recovery at 3 mo. PATIENT SUMMARY: 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.
Authors: Markus A Küper; Alexander Trulson; Jonas Johannink; Bernhard Hirt; Artur Leis; Max Hoßfeld; Tina Histing; Steven C Herath; Bastian Amend Journal: J Robot Surg Date: 2022-02-11
Authors: Sigrun Holze; Max Bräunlich; Meinhard Mende; Vinodh-Kumar-Adithyaa Arthanareeswaran; Petra Neuhaus; Michael C Truss; Hoang Minh Do; Anja Dietel; Toni Franz; Dogu Teber; Ann-Kathrin Heilsberg; Markus Hohenfellner; Robert Rabenalt; Peter Albers; Jens-Uwe Stolzenburg Journal: World J Urol Date: 2022-02-06 Impact factor: 4.226