Clinical trial NCT03706508: Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy
Official title: Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Erectile Dysfunction
Complication of Surgical Procedure
Urinary Incontinence
Keywords: Robot-assisted prostatectomy
Pentafecta
Biochemical failure
Surgical margin
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 40 and 75 diagnosed with localized prostate cancer submitted to robot-assisted laparoscopic radical prostatectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Erectile Dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: Urinary Continence
timeFrame: 6 months
measure: Surgical Complication
timeFrame: 30 days
measure: Biochemical Failure
timeFrame: 6 month
measure: Surgical Margin
timeFrame: 15 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Brasil S Neto, PhD
role: PRINCIPAL_INVESTIGATOR
References: