Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence; Erectile Dysfunction; Prostate Cancer; Complication of Surgical Procedure
• Intervention / Treatment: Procedure: Robot-assisted laparoscopic radical prostatectomy

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035 007
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Brasil S Neto, PhD; Phone Number: +55 51 33598286; Email: bneto@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients between 40 and 75 diagnosed with localized prostate cancer submitted to robot-assisted laparoscopic radical prostatectomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile Dysfunction	Sexual Health Inventory for Men (SHIM) score greater or equal to 21.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Continence	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.	6 months
Surgical Complication	Complications were categorized according to the Clavien classification system.	30 days
Biochemical Failure	Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.	6 month
Surgical Margin	It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece.	15 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Brasil S Neto, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2013
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Robot-assisted prostatectomy; Pentafecta; Biochemical failure; Surgical margin
• Additional Relevant MeSH Terms: Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urinary Incontinence; Erectile Dysfunction
• Other Study ID Numbers: 2016/0457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No