Prostate Cancer Clinical Trial
Official title:
Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
Verified date | November 2017 |
Source | Azienda Ospedaliera Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 226 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Clinical Department of Urology, university Hospital Spedali Civili di Brescia | Brescia |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative estimated bool loss | intraoperative | ||
Secondary | Transfusion rate | 30 days from surgery | ||
Secondary | Overall positive surgical marigins | intraoperative | ||
Secondary | Apical positive surgicals margins | intraoperative | ||
Secondary | 1-month continence | 0 or 1 security pad per day | 30 days from surgery | |
Secondary | 1-month PSA | 30 days from surgery |
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