search
Back to results

Early DVC Ligation and Urinary Continence Recovery After RARP

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Early DVC ligation
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radical prostatectomy, deep venous complex ligation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • IRCCS Ospedale San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Early urinary continence recovery
Continence recovery evaluated with the ICIQ-SF questionnaire

Secondary Outcome Measures

Urinary continence recovery
Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire
Erectile function recovery
Erectile function recovery evaluated with the IIEF questionnaire
Positive surgical margins
Positive surgical margins
PSA persistence or biochemical recurrence
Serum PSA levels
Perioperative outcomes
Postoperative complications according to the Clavien-Dindo classification

Full Information

First Posted
November 30, 2017
Last Updated
September 22, 2020
Sponsor
IRCCS San Raffaele
search

1. Study Identification

Unique Protocol Identification Number
NCT03368378
Brief Title
Early DVC Ligation and Urinary Continence Recovery After RARP
Official Title
Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, radical prostatectomy, deep venous complex ligation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm 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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Early DVC ligation
Intervention Description
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 Measure Information:
Title
Early urinary continence recovery
Description
Continence recovery evaluated with the ICIQ-SF questionnaire
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Urinary continence recovery
Description
Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire
Time Frame
16 weeks
Title
Erectile function recovery
Description
Erectile function recovery evaluated with the IIEF questionnaire
Time Frame
16 weeks
Title
Positive surgical margins
Description
Positive surgical margins
Time Frame
4 weeks
Title
PSA persistence or biochemical recurrence
Description
Serum PSA levels
Time Frame
4, 16 and 48 weeks
Title
Perioperative outcomes
Description
Postoperative complications according to the Clavien-Dindo classification
Time Frame
30 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Early DVC Ligation and Urinary Continence Recovery After RARP

We'll reach out to this number within 24 hrs