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Trial record 78 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

Early DVC Ligation and Urinary Continence Recovery After RARP

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ClinicalTrials.gov Identifier: NCT03368378
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Francesco Montorsi, IRCCS San Raffaele

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Early DVC ligation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Group 1
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
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.

Active Comparator: Group 2
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
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 Outcome Measures :
  1. Early urinary continence recovery [ Time Frame: 4 weeks ]
    Continence recovery evaluated with the ICIQ-SF questionnaire


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368378


Locations
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Italy
IRCCS Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Francesco Montorsi, Prof.    +390226437286    montorsi.francesco@hsr.it   
Contact: Giorgio Gandaglia, MD    +390226437286    gandaglia.giorgio@hsr.it   
Principal Investigator: Francesco Montorsi, MD         
Sub-Investigator: Alberto Briganti, MD         
Sub-Investigator: Giorgio Gandaglia, MD         
Sub-Investigator: Elio Mazzone, MD         
Sponsors and Collaborators
IRCCS San Raffaele

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Responsible Party: Francesco Montorsi, MD, FRCS (Hon), Professor and Chairman, Department of Urology Vita e Salute San Raffaele University, Milan, Italy, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03368378     History of Changes
Other Study ID Numbers: IRCCSSRaffaele
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francesco Montorsi, IRCCS San Raffaele:
prostate cancer
radical prostatectomy
deep venous complex ligation

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases