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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: DVC ligation

• Registration Number: NCT03351088
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-19
• Last Update Submitted: 2017-11-19
• Study First Posted: 2017-11-22
• Last Update Posted: 2017-11-22
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive ligation	DVC 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.
Delayed ligation	DVC 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).

Primary Outcome Measures

Name	Time	Method
Intraoperative estimated bool loss	intraoperative

Secondary Outcome Measures

Name	Time	Method
Overall positive surgical marigins	intraoperative
Apical positive surgicals margins	intraoperative
Transfusion rate	30 days from surgery
1-month continence	30 days from surgery	0 or 1 security pad per day
1-month PSA	30 days from surgery

Trial Locations

Locations (1)

Clinical Department of Urology, university Hospital Spedali Civili di Brescia; 🇮🇹 Brescia, Italy