MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

Prospective Randomised Study to Examine the Influence of a Modification of the DaVinci Prostatectomy on the Frequency of Postoperative Lymphoceles Requiring Treatment and Postoperative Complications

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy 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 at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.

Inclusion Criteria:

• Declaration of consent signed
• Minimum age 18 years
• localised prostate carcinoma
• planned DVRP with bilateral lymphadenectomy

Exclusion Criteria:

• patient's lack of capacity to consent
• ORP
• no planned PLND
• metastatic prostate cancer
• ASA status >3