The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.
Study Type
OBSERVATIONAL
Enrollment
70
Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Time to perform the vesicourethral anastomosis
Time to perform the vesicourethral anastomosis using a stopwatch. Time starts when the needle passes the first time the tissue and ends after completion of the anastomosis. Completion of the anastomosis is defined by the last cut of the thread.
Time frame: intraoperatively
Anastomotic leak rate until 6 months postoperatively
Cumulative number of anastomotic leaks
Time frame: up to 6 months after surgery
Amount of estimate blood loss (EBL)
Blood loss is estimated by the amount of intraoperatively needed transfusion
Time frame: intraoperatively
Transfusion rate
Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag
Time frame: at discharge from hospital (approximately 5-10 days after surgery)
Urinary retention
Urinary retention is an inability to completely empty the bladder
Time frame: at 6 weeks postoperatively
Urinary fistula rate
A urogenital fistula is an abnormal tract that exists between the urinary tract and bladder, ureters, or urethra. A urogenital fistula can occur between any of the organs and structures of the pelvic region. A fistula allows urine to continually exit through and out the urogenital tract.
Time frame: until 6 months postoperatively
Bladder neck contracture rate
Cumulative rate of patients with a complication related to the bladder neck contracture
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Time frame: until 6 months postoperatively
Urinary stone formation rate
Cumulative rate of patients with a complication related to urinary stone formation
Time frame: until 6 months postoperatively
Rate of other complications
Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)
Time frame: until 6 months postoperatively
Operation consola time
Time to perform the intervention from first cut to last cut of the last thread. The time is measured using a stopwatch.
Time frame: intraoperatively
Time to perform the Rocco stitch
Time to perform the modified Rocco stitch: After prostate extirpation, the free edge of the Denonvillier fascia is approximated to the posterior rhabdosphincter/median raphe using a running suture. Then, the Denonvilliers' fascia is fixated to the posterior wall of the bladder, which reduces tension in the anastomosis and provides pelvic support to the bladder neck. The time is measured using a stopwatch.
Time frame: intraoperatively
Length of postoperative stay
Number of days from surgery till patient is discharged from hospital
Time frame: until discharge (approximately 5-10 days postoperatively)
Catheterization duration
Number of days from surgery till catheter was finally removed
Time frame: until first follow-up (6 weeks postoperatively)
Early continence
Days after catheter was finally removed to complete continence
Time frame: 6 weeks postoperatively
Development of continence by 24-h pad test
The 24-hour pad test is used as an objective diagnostic method for the assessment of post prostatectomy stress urinary incontinence. Pads are weighed before and after use and the amount of urine is measured.
Time frame: at 3 months and 6 months postoperatively.
Development of Erectile Function compared to baseline
Erectile Function measured by International Index of Erectile Function (IIEF-5). The International Index of Erectile Function-5 (IIEF-5) is an five-item Index developed to diagnose the presence and severity of erectile dysfunction (ED). The five items are based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health's definition of ED. These items focus on erectile function and intercourse satisfaction. The items are rated on a scale from 1-5 (e.g., 1=Very low to 5=Very high; 1=Almost never/never to 5=Almost always/always; 1=Extremely difficult to 5=Not difficult). The IIEF-5 score is the sum of questions 1 to 5 (Scores range from 5-25). ED was classified into five severity levels, ranging from none (22-25) through severe (5-7).
Time frame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
Development of International prostate symptom score (IPSS) compared to baseline
The International prostate symptom score (IPSS) questionnaire has seven questions, which are used to evaluate storage and voiding symptoms. The patient is given five options for the first seven questions and each option indicates severity of that symptom. The total score ranges from 0 to 35 and Lower Urinary Tract Symptoms (LUTS) are classified as mild to severe depending on the total score. Patients having a total score ≤7 are classified as having mild symptoms, scores from 8 to 19 are classified as moderate symptoms, and symptom scores ≥20 are classified as severe symptoms.
Time frame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
Comparison of Prostate Specific Antigen (PSA) at screening and 6 weeks after surgery.
PSA response will be measured as the change of serum PSA in ng/mL between preoperative / screening examination and at follow-up 6 weeks after surgery
Time frame: at screening and 6 weeks after surgery.