To test the impact of fixing a peritoneal flap of the bladder to the plexus Santorini as final step of robot-assisted radical prostatectomy (RARP) to reduce the incidence of symptomatic lymphoceles and postoperative complications.
A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent RARP with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini (Michl-technique, MT) at the end of surgery; in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. Secondary endpoints were total lymphocele rate and other complications ≥ grade IIIa according to Clavien-Dindo as well as continence rates within one year after RARP.
Overall, between June 2017 and October 2019, 531 patients were randomised to the MT arm and 549 to the control arm. There were no differences in both arms with respect to age at surgery, PSA, BMI, prostate volume, surgical time, blood loss, and time to removal of the catheter. In median 14 lymph nodes were dissected in both groups. There was no statistically significant difference in the lymphoceles requiring intervention (7.2% in MT-group versus 8.8% in control group, p=0.4). There was no difference in continence rates and other complications between the two groups after 12 months of follow-up.
There was no significant reduction in symptomatic lymphoceles observed when using Michl technique. Lymphoceles remain a significant complication post lymph node dissection in RARP patients.