Early DVC Ligation and Urinary Continence Recovery After RARP

NCT03368378 | Completed DMC

• 1 other identifier: eDVCL
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; radical prostatectomy; deep venous complex ligation

Outcome Measures

Primary Outcomes (1)

• Early urinary continence recovery

  Continence recovery evaluated with the ICIQ-SF questionnaire

  4 weeks

Secondary Outcomes (5)

• Urinary continence recovery

  16 weeks

• Erectile function recovery

  16 weeks

• Positive surgical margins

  4 weeks

• PSA persistence or biochemical recurrence

  4, 16 and 48 weeks

• Perioperative outcomes

  30 days

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Interventions

Early DVC ligation PROCEDURE

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCS (Hon), Professor and Chairman, Department of Urology Vita e Salute San Raffaele University, Milan, Italy

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 11, 2017
• Study Start: November 28, 2017
• Primary Completion: October 30, 2019
• Study Completion: February 10, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

IT (1)