Upcoming event

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

  • 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

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.