Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

• Conditions: Erectile Dysfunction; Complication of Surgical Procedure; Prostate Cancer; Urinary Incontinence

• Registration Number: NCT03706508
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

Detailed Description

This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.

Study Timeline

• Study Start: 2013-08-09
• Status Verified: 2018-09
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• patients diagnosed with localized Prostate Adenocarcinoma submitted to surgical treatment with Robot-assisted laparoscopic radical prostatectomy

Exclusion Criteria

• patients undergoing other treatments for adenocarcinoma of the prostate
• conversion to open prostatectomy
• loss of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erectile Dysfunction	6 months	Sexual Health Inventory for Men (SHIM) score greater or equal to 21.

Secondary Outcome Measures

Name	Time	Method
Surgical Margin	15 days	It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece.
Biochemical Failure	6 month	Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.
Surgical Complication	30 days	Complications were categorized according to the Clavien classification system.
Urinary Continence	6 months	Continence was defined as patients who remain dry and who do not require any kind of protection.Patients will be questioned in the postoperative consultations if there is a need to use some protection.

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil