Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy
NCT ID: NCT03351088
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
226 participants
INTERVENTIONAL
2016-08-31
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Preventive ligation
Preventive ligation of DVC is done after the opening of endopelvic fascia and before bladder neck dissection. DVC is ligated at the level of the apex with a 8-fashion single stich (1-0 Monocryl® CT-1 stich) trying to preserve puboprostatic ligaments and the muscle fibres of the rabdosphincter. DVC is then dissected at the end of prostatectomy before the section of the urethra.
DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Delayed ligation
Delayed ligation is done after the section of the urethra and once the prostatectomy is completed with a single stich (3-0 Monocryl® UR-6).
DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Interventions
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DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Eligibility Criteria
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Inclusion Criteria
* patients willing and able to provide written informed consent
* voluntary partecipation
* clinical indication to robot-assisted radical prostatectomy
Exclusion Criteria
* salvage radical prostatectomy
18 Years
80 Years
MALE
No
Sponsors
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Responsible Party
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Alessandro Antonelli
Dirigente medico
Locations
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Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Brescia, , Italy
Countries
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Other Identifiers
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DVC
Identifier Type: -
Identifier Source: org_study_id