NCT06284135
Completed
N/A
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
ConditionsLymphocele After Surgical Procedure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lymphocele After Surgical Procedure
- Sponsor
- Martini-Klinik am UKE GmbH
- Enrollment
- 1080
- Locations
- 1
- Primary Endpoint
- rate of lymphoceles requiring intervention after RARP
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •no planned PLND
- •metastatic prostate cancer
- •ASA status \>3
Outcomes
Primary Outcomes
rate of lymphoceles requiring intervention after RARP
Time Frame: one year follow-up
Clavien-Dindo \>2°
Secondary Outcomes
- total lymphocele rate after RARP(one year follow-up)
- other complications ≥ grade IIIa according to Clavien-Dindo after RARP(one year follow-up)
- continence rates after RARP(one year folow-up)
Study Sites (1)
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