Finished
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles
NCT06284135 · Martini-Klinik am UKE GmbH · Updated 28 Feb 2024
- What is being tested
- Michl-stitch
- For
- Lymphocele After Surgical Procedure
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 1,080 people. The full rules are on the registry page.
- Where
- Germany
- When
- Starts or started 19 June 2017, ends 31 May 2021. Registered 28 Feb 2024.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Martini-Klinik am UKE GmbHHamburg, Germany