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Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DVC ligation
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • male patients, aged 18-80 years
  • patients willing and able to provide written informed consent
  • voluntary partecipation
  • clinical indication to robot-assisted radical prostatectomy

Exclusion Criteria:

  • coagulation impairment at the time of surgery
  • salvage radical prostatectomy

Sites / Locations

  • Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Preventive ligation

Delayed ligation

Arm Description

Preventive ligation of DVC is done after the opening of endopelvic fascia and before bladder neck dissection. DVC is ligated at the level of the apex with a 8-fashion single stich (1-0 Monocryl® CT-1 stich) trying to preserve puboprostatic ligaments and the muscle fibres of the rabdosphincter. DVC is then dissected at the end of prostatectomy before the section of the urethra.

Delayed ligation is done after the section of the urethra and once the prostatectomy is completed with a single stich (3-0 Monocryl® UR-6).

Outcomes

Primary Outcome Measures

Intraoperative estimated bool loss

Secondary Outcome Measures

Transfusion rate
Overall positive surgical marigins
Apical positive surgicals margins
1-month continence
0 or 1 security pad per day
1-month PSA

Full Information

First Posted
November 19, 2017
Last Updated
November 19, 2017
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT03351088
Brief Title
Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy
Official Title
Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

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

5. Study Description

Brief Summary
Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities. The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients. Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preventive ligation
Arm Type
Other
Arm Description
Preventive ligation of DVC is done after the opening of endopelvic fascia and before bladder neck dissection. DVC is ligated at the level of the apex with a 8-fashion single stich (1-0 Monocryl® CT-1 stich) trying to preserve puboprostatic ligaments and the muscle fibres of the rabdosphincter. DVC is then dissected at the end of prostatectomy before the section of the urethra.
Arm Title
Delayed ligation
Arm Type
Other
Arm Description
Delayed ligation is done after the section of the urethra and once the prostatectomy is completed with a single stich (3-0 Monocryl® UR-6).
Intervention Type
Procedure
Intervention Name(s)
DVC ligation
Intervention Description
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Primary Outcome Measure Information:
Title
Intraoperative estimated bool loss
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Transfusion rate
Time Frame
30 days from surgery
Title
Overall positive surgical marigins
Time Frame
intraoperative
Title
Apical positive surgicals margins
Time Frame
intraoperative
Title
1-month continence
Description
0 or 1 security pad per day
Time Frame
30 days from surgery
Title
1-month PSA
Time Frame
30 days from surgery

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 18-80 years patients willing and able to provide written informed consent voluntary partecipation clinical indication to robot-assisted radical prostatectomy Exclusion Criteria: coagulation impairment at the time of surgery salvage radical prostatectomy
Facility Information:
Facility Name
Clinical Department of Urology, university Hospital Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy

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