Trials / Unknown
UnknownNCT03706508
Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy
Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (estimated)
- Sponsor
- Hospital de Clinicas de Porto Alegre · Academic / Other
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Robot-assisted laparoscopic radical prostatectomy | Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy |
Timeline
- Start date
- 2013-08-09
- Primary completion
- 2018-11-30
- Completion
- 2018-11-30
- First posted
- 2018-10-16
- Last updated
- 2018-10-30
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03706508. Inclusion in this directory is not an endorsement.