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

NCT03351088 | Unknown

• 1 other identifier: DVC
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Intraoperative estimated bool loss

  intraoperative

Secondary Outcomes (5)

• Transfusion rate

  30 days from surgery

• Overall positive surgical marigins

  intraoperative

• Apical positive surgicals margins

  intraoperative

• 1-month continence

  30 days from surgery

• 1-month PSA

  30 days from surgery

Study Arms (2)

Preventive ligation

OTHER

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

Delayed ligation

OTHER

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

Interventions

DVC ligation PROCEDURE

Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy

Delayed ligation; Preventive ligation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dirigente medico

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: November 22, 2017
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

IT (1)