Trials / Unknown
UnknownNCT03351088
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | DVC ligation | Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-11-01
- Completion
- 2017-12-01
- First posted
- 2017-11-22
- Last updated
- 2017-11-22
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03351088. Inclusion in this directory is not an endorsement.