Adverse Events During Radical Prostatectomy and Their Association With Reccurence and Death

Objective The objective was to explore if adverse events during radical prostatectomy for prostate cancer were associated with the oncological outcomes recurrence, all-cause and prostate cancer specific mortality. One further was to identify risk factors for adverse events. Methods A post-hoc study nested in a prospective, controlled trial of radical prostatectomy by robot assisted laparoscopic or open retropubic approach in Sweden. Adverse events during surgery were collected by clinical record forms (CRFs) filled out by the surgeon at operation. Recurrence was identified by CRFs and patient reports, cause of death through the Swedish National Cause of Death register. Recurrence was defined as undetectable PSA 6-12 weeks after prostatectomy followed by PSA >0.25 ng/ml or treatment for prostate cancer recurrence. Cox regression was used to explore associations between exposure and outcome. Results One/more adverse events occurred during 39% (1356/ 3444) of operations. Adverse events were associated with recurrence, but not with all-cause or prostate cancer specific mortality. Intraoperative extensive bleeding and difficulties during dissection were associated with recurrence. Risk factors included age at surgery, history of TUR-P or abdominal surgery, teaching, prostate weight and lymph node dissection. Limitations included the low number of observations (deaths), particularly in subgroup analyses and hospital volume. This study should be regarded as explorative. Conclusions Adverse events during radical prostatectomy were associated with increased risk for recurrence. Intraoperative bleeding and difficulties during dissection were individual risk factors for recurrence. Risk factors for adverse events were age, prostate weight, prior abdominal surgery and lymph node dissection.