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

November 19, 2017 updated by: Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preventive ligation
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.
Procedure: DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Other: Delayed ligation
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).
Procedure: DVC ligation
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative estimated bool loss
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion rate
Time Frame: 30 days from surgery
30 days from surgery
Overall positive surgical marigins
Time Frame: intraoperative
intraoperative
Apical positive surgicals margins
Time Frame: intraoperative
intraoperative
1-month continence
Time Frame: 30 days from surgery
0 or 1 security pad per day
30 days from surgery
1-month PSA
Time Frame: 30 days from surgery
30 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 19, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 19, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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