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Clinical Trials/NCT03351088
NCT03351088
Unknown
Not Applicable

Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 site in 1 country226 target enrollmentAugust 2016
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Enrollment
226
Locations
1
Primary Endpoint
Intraoperative estimated bool loss
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alessandro Antonelli

Dirigente medico

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Eligibility Criteria

Inclusion Criteria

  • male patients, aged 18-80 years
  • patients willing and able to provide written informed consent
  • voluntary partecipation
  • clinical indication to robot-assisted radical prostatectomy

Exclusion Criteria

  • coagulation impairment at the time of surgery
  • salvage radical prostatectomy

Outcomes

Primary Outcomes

Intraoperative estimated bool loss

Time Frame: intraoperative

Secondary Outcomes

  • Overall positive surgical marigins(intraoperative)
  • Apical positive surgicals margins(intraoperative)
  • Transfusion rate(30 days from surgery)
  • 1-month continence(30 days from surgery)
  • 1-month PSA(30 days from surgery)

Study Sites (1)

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