Early DVC Ligation and Urinary Continence Recovery After RARP

San Donato Group (GSD)

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Early DVC ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT03368378

eDVCL

Details and patient eligibility

About

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.

Enrollment: 312 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male patients, aged between 18 and 80 years old
2. Planned to receive robot-assisted radical prostatectomy for prostate cancer
3. Able to understand and willing to sign a written informed consent document
4. 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:

1. Life expectancy of less than 12 months
2. Previous chemotherapy
3. Previous brachytherapy or external beam radiotherapy
4. Preexisting urinary incontinence defined as 1 or more pads per day
5. Unstable cardiovascular disease
6. Congestive Heart Failure (CHF)
7. Clinically significant hepatobiliary or renal disease
8. History of significant CNS injuries within 6 months
9. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Procedure: Early DVC ligation

Group 2

Active Comparator group

Description:

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.

Treatment:

Procedure: Early DVC ligation