Status:
COMPLETED
Early DVC Ligation and Urinary Continence Recovery After RARP
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prosta...
Eligibility Criteria
Inclusion
- Male patients, aged between 18 and 80 years old
- Planned to receive robot-assisted radical prostatectomy for prostate cancer
- Able to understand and willing to sign a written informed consent document
- On stable dose of current regular medication for at least 4 weeks prior to trial entry
Exclusion
- The participant may not enter the trial if ANY of the following apply:
- Life expectancy of less than 12 months
- Previous chemotherapy
- Previous brachytherapy or external beam radiotherapy
- Preexisting urinary incontinence defined as 1 or more pads per day
- Unstable cardiovascular disease
- Congestive Heart Failure (CHF)
- Clinically significant hepatobiliary or renal disease
- History of significant CNS injuries within 6 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2020
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT03368378
Start Date
November 28 2017
End Date
February 10 2020
Last Update
September 23 2020
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132