Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706508
• Other study ID #: 2016/0457
• Status: Recruiting
• Start date: August 9, 2013
• Est. completion date: November 30, 2018

Study information

• Verified date: September 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Brasil S Neto, PhD
• Phone: +55 51 33598286
• Email: bneto[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Enuresis
• Erectile Dysfunction
• Prostate Cancer
• Urinary Incontinence

Intervention

Procedure:
• Robot-assisted laparoscopic radical prostatectomy
Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Dysfunction	Sexual Health Inventory for Men (SHIM) score greater or equal to 21.	6 months
Secondary	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
Secondary	Surgical Complication	Complications were categorized according to the Clavien classification system.	30 days
Secondary	Biochemical Failure	Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.	6 month
Secondary	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