Early DVC Ligation and Urinary Continence Recovery After RARP

Prostate Cancer Clinical Trial

Official title:

Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368378
• Other study ID #: eDVCL
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: February 10, 2020

Study information

• Verified date: September 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: February 10, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Early DVC ligation
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. This approach would allow for the preservation of the external urethral sphincter and for the identification and preservation of the neurovascular bundles that are located in the anterolateral aspect of the prostate. 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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early urinary continence recovery	Continence recovery evaluated with the ICIQ-SF questionnaire	4 weeks
Secondary	Urinary continence recovery	Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire	16 weeks
Secondary	Erectile function recovery	Erectile function recovery evaluated with the IIEF questionnaire	16 weeks
Secondary	Positive surgical margins	Positive surgical margins	4 weeks
Secondary	PSA persistence or biochemical recurrence	Serum PSA levels	4, 16 and 48 weeks
Secondary	Perioperative outcomes	Postoperative complications according to the Clavien-Dindo classification	30 days