NCT03368378

Early DVC Ligation and Urinary Continence Recovery After RARP

Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Early DVC ligation	After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The DVC will be identified and incised. The DVC will be then selectively ligated using a V-lok 3/0 barbed suture. This approach would allow for the preservation of the external urethral sphincter and for the identification and preservation of the neurovascular bundles that are located in the anterolateral aspect of the prostate. After the early DVC isolation, incision and ligation, the bladder neck will be incised and preserved when possible. A posterior nerve sparing approach will be then performed. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-10-30
• Completion: 2020-02-10
• First posted: 2017-12-11
• Last updated: 2020-09-23

Locations

1 site across 1 country: Italy