1. Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01)
- Author
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Dogu Teber, Sigrun Holze, Iason Kyriazis, Meinhard Mende, Peter Albers, Corinn I. Grzella, Petra Neuhaus, Robert Rabenalt, Hoang Minh Do, Anja Dietel, Michael C. Truss, Markus Hohenfellner, and Jens-Uwe Stolzenburg
- Subjects
Laparoscopic surgery ,Male ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Randomized controlled trial ,Robotic Surgical Procedures ,law ,Clinical endpoint ,Medicine ,Humans ,Prostatectomy ,business.industry ,Hazard ratio ,Prostate ,Prostatic Neoplasms ,Surgery ,Treatment Outcome ,030220 oncology & carcinogenesis ,Laparoscopic Prostatectomy ,Quality of Life ,Prostate surgery ,Laparoscopy ,business - 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.
- Published
- 2020