Early DVC Ligation and Urinary Continence Recovery After RARP

Not Applicable

Completed

• Conditions: Prostate Cancer

• 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

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
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
Perioperative outcomes	30 days	Postoperative complications according to the Clavien-Dindo classification

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy