Early DVC Ligation and Urinary Continence Recovery After RARP

IRCCS San Raffaele312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

312

Conditions

Prostate Cancer

Interventions

Early DVC ligationPROCEDURE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

Early urinary continence recovery

Continence recovery evaluated with the ICIQ-SF questionnaire

Time frame: 4 weeks

Secondary Outcomes

Urinary continence recovery

Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire

Time frame: 16 weeks

Erectile function recovery

Erectile function recovery evaluated with the IIEF questionnaire

Time frame: 16 weeks

Positive surgical margins

Time frame: 4 weeks

PSA persistence or biochemical recurrence

Serum PSA levels

Time frame: 4, 16 and 48 weeks

Perioperative outcomes

Postoperative complications according to the Clavien-Dindo classification

Time frame: 30 days

Data from ClinicalTrials.gov

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