Prostatic Neoplasms
Conditions
Interventions
This is a prospective randomized blinded clinical trial.Experimental group: 36 patients with prostate cancer will undergo laparoscopic radical prostatectomy with preservation of the pubovesical comple
Sponsors
Centro Universitário de João Pessoa
Centro Universitário de João Pessoa
Eligibility
Sex/Gender
Male
Age
No minimum to 75 Years
Inclusion criteria
Inclusion criteria: Patients with low and intermediate risk prostate cancer (National Comprehensive Cancer Network); age below 75 years; normal preoperative continence
Exclusion criteria
Exclusion criteria: Preoperative urinary incontinence; prostate volume greater than 80 ml; use of neoadjuvant therapy; prostate, bladder or urethral surgery; biopsy with involvement of the anterior region of the prostate; vascular or neurological comorbidities with voiding or sexual impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: A higher rate of immediate continence is expected with the use of the pubovesical complex preservation technique in laparoscopic radical prostatectomy. Immediate Urinary continence was defined as complete absence of urinary leakage or zero pads in assessment 24 hours after removal of the urinary catheter;Outcome found 1: We observed no statistical difference in the rate of immediate continence with the use of the pubovesical complex preservation technique in laparoscopic radical prostatectomy ;Expected outcome 2: A higher rate of early continence is expected with the use of the pubovesical complex preservation technique in laparoscopic radical prostatectomy. Early continence was defined as complete absence of urinary leakage or zero pads in assessments 15 days, 1, 3 and 6 months after removal of the urinary catheter.;Outcome found 2: We found a higher rate of early continence at the 6-month evaluation (82.4% vs 57.6%) with the use of the pubovesical complex preservation technique in laparoscopic radical prostatectomy. We found no statistical difference in the other periods of analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: We expect to find a similar operative time between the techniques studied, measured in minutes from the beginning of creation of the pneumoperitoneum until the removal of the surgical specimen.;Finding 3: We found longer operative time with the technique of preserving the pubovesical complex in laparoscopic radical prostatectomy;Expected outcome 4: It is expected to find a similar blood loss between the techniques studied, measured in milliliters and estimated through the total blood volume collected by the aspirator, subtracting the initial volume of urine and saline aspirated;Expected outcome 5: It is expected to find similar length of hospital stay between the techniques studied, measured in days of hospital stay after the surgical procedure;Outcome found 5: No difference was observed between hospital stay times between the techniques studied ?;Expected outcome 6: It is expected to find similar rates of intraoperative and postoperative complications between the surgical techniques studied. Intraoperative complications defined as injuries to adjacent organs or structures and anatomical technical difficulties. Postoperative complications measured according to the modified Clavien classification, as follows: early (up to 30 days) and late (>90 days);Outcome found 6: No statistical difference was observed in the occurrence of complications between the surgical techniques studied, both intraoperatively and postoperatively;Expected outcome 7: It is expected to find similar rates of compromised surgical margins between the surgical techniques studied. Evaluated through anatomopathological study;Outcome found 7: We observed no difference in the occurrence of compromised margins between the techniques studied | — |
Countries
Brazil
Contacts
Public ContactRafael Rebouças
Centro Universitário de João Pessoa
Outcome results
None listed