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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03351088

Enrollment

226

Registered

2017-11-22

Start date

2016-08-31

Completion date

2017-12-31

Last updated

2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

PROCEDUREDVC ligation

Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Intraoperative estimated bool loss	intraoperative

Secondary

Measure	Time frame	Description
Transfusion rate	30 days from surgery	—
Overall positive surgical marigins	intraoperative	—
Apical positive surgicals margins	intraoperative	—
1-month continence	30 days from surgery	0 or 1 security pad per day
1-month PSA	30 days from surgery	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026