Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer, Erectile Dysfunction, Complication of Surgical Procedure, Urinary Incontinence

Intervention / Treatment
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* Procedure: Robot-assisted laparoscopic radical prostatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Robot-assisted laparoscopic radical prostatectomy|Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot-assisted prostatectomy, Pentafecta, Biochemical failure, Surgical margin