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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03351088
Other study ID # DVC
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 19, 2017
Last updated November 19, 2017
Start date August 2016
Est. completion date December 2017

Study information

Verified date November 2017
Source Azienda Ospedaliera Spedali Civili di Brescia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy

Locations

Country Name City State
Italy Clinical Department of Urology, university Hospital Spedali Civili di Brescia Brescia

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

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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