Early DVC Ligation and Urinary Continence Recovery After RARP

Not Applicable

Completed

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

• Registration Number: NCT03368378
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Primary Completion: 2019-10-30
• Study Completion: 2020-02-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Early DVC ligation	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.
Group 1	Early DVC ligation	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.

Primary Outcome Measures

Name	Time	Method
Early urinary continence recovery	4 weeks	Continence recovery evaluated with the ICIQ-SF questionnaire

Secondary Outcome Measures

Name	Time	Method
Perioperative outcomes	30 days	Postoperative complications according to the Clavien-Dindo classification
Erectile function recovery	16 weeks	Erectile function recovery evaluated with the IIEF questionnaire
PSA persistence or biochemical recurrence	4, 16 and 48 weeks	Serum PSA levels
Urinary continence recovery	16 weeks	Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire
Positive surgical margins	4 weeks	Positive surgical margins

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy