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Clinical Trials/NCT06284135
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

Martini-Klinik am UKE GmbH1 site in 1 country1,080 target enrollmentJune 19, 2017

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.

Registry
clinicaltrials.gov
Start Date
June 19, 2017
End Date
May 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

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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