MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles
Not Applicable
Completed
- Conditions
- Lymphocele After Surgical Procedure
- Interventions
- Other: Michl-stitch
- Registration Number
- NCT06284135
- Lead Sponsor
- Martini-Klinik am UKE GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1080
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Michl-stitch Michl-stitch -
- Primary Outcome Measures
Name Time Method rate of lymphoceles requiring intervention after RARP one year follow-up Clavien-Dindo \>2°
- Secondary Outcome Measures
Name Time Method total lymphocele rate after RARP one year follow-up Clavien-Dindo
other complications ≥ grade IIIa according to Clavien-Dindo after RARP one year follow-up Clavien-Dindo
continence rates after RARP one year folow-up EPIC
Trial Locations
- Locations (1)
Martini-Klinik am UKE GmbH
🇩🇪Hamburg, Germany