Early DVC Ligation and Urinary Continence Recovery After RARP

Study Overview
=================
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 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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Early DVC ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>During robot-assisted radical prostatectomy 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. 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. | Procedure: Early DVC ligation<br>* 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.<br>|
| Active Comparator: Group 2<br>After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The bladder neck will be then incised and preserved when possible. An inter-fascial or intra-fascial nerve-sparing technique will be then performed and the posterolateral aspect of the neurovascular bundles will be preserved. The DVC will be then isolated and selectively ligated using a V-lok 3/0 barbed suture. The anterolateral fibers of the neurovascular bundles will be then identified and preserved when possible. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed. | Procedure: Early DVC ligation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early urinary continence recovery | Continence recovery evaluated with the ICIQ-SF questionnaire | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence recovery | Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire | 16 weeks | 
| Erectile function recovery | Erectile function recovery evaluated with the IIEF questionnaire | 16 weeks | 
| Positive surgical margins | Positive surgical margins | 4 weeks | 
| PSA persistence or biochemical recurrence | Serum PSA levels | 4, 16 and 48 weeks | 
| Perioperative outcomes | Postoperative complications according to the Clavien-Dindo classification | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, radical prostatectomy, deep venous complex ligation