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Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy

NCT03351088 · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated 22 Nov 2017

What is being tested
DVC ligation
For
Prostate Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 226 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Aug 2016, ends Dec 2017. Registered 22 Nov 2017.
Results
None posted yet.

In the researchers' words

Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities. The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients. Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.
ClinicalTrials.gov, NCT03351088

Sites

  • Clinical Department of Urology, university Hospital Spedali Civili di BresciaBrescia, Italy