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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,080
In the intervention group, a ventral fixation was performed by suturing the ventral bladder peritoneum to the plexus Santorini and from there to the right and left lateral endopelvic fascia (MICHL-stitch).
Martini-Klinik am UKE GmbH
Hamburg, Germany
rate of lymphoceles requiring intervention after RARP
Clavien-Dindo \>2°
Time frame: one year follow-up
total lymphocele rate after RARP
Clavien-Dindo
Time frame: one year follow-up
other complications ≥ grade IIIa according to Clavien-Dindo after RARP
Clavien-Dindo
Time frame: one year follow-up
continence rates after RARP
EPIC
Time frame: one year folow-up
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