Complication of Surgical Procedure, Erectile Dysfunction, Prostate Cancer, Urinary Incontinence
Conditions
Keywords
Robot-assisted prostatectomy, Pentafecta, Biochemical failure, Surgical margin
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.
Interventions
PROCEDURERobot-assisted laparoscopic radical prostatectomy
Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction | 6 months | Sexual Health Inventory for Men (SHIM) score greater or equal to 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Failure | 6 month | Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml. |
| Surgical Margin | 15 days | It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece. |
| Urinary Continence | 6 months | 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. |
| Surgical Complication | 30 days | Complications were categorized according to the Clavien classification system. |
Countries
Brazil
Contacts
Primary ContactBrasil S Neto, PhD
Backup ContactEduardo T Cachoeira, MD
Outcome results
None listed