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OpenTrials
Completed

NCT Number: NCT03368378

Early DVC Ligation and Urinary Continence Recovery After RARP

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Early urinary continence recovery

    Time frame: 4 weeks

    Continence recovery evaluated with the ICIQ-SF questionnaire

Secondary outcomes

  1. Urinary continence recovery

    Time frame: 16 weeks

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

  2. Erectile function recovery

    Time frame: 16 weeks

    Erectile function recovery evaluated with the IIEF questionnaire

  3. Positive surgical margins

    Time frame: 4 weeks

    Positive surgical margins

  4. PSA persistence or biochemical recurrence

    Time frame: 4, 16 and 48 weeks

    Serum PSA levels

  5. Perioperative outcomes

    Time frame: 30 days

    Postoperative complications according to the Clavien-Dindo classification

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2017
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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