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