Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.

Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study

robotic assisted radical prostatectomy

Irene Fita Esteban

Anna Ibañez Jimenez

Miguel Sánchez Encinas, Dr.

Carlos Hernandez Rios, Dr.

Dr. Miguel Sánchez Encinas, Dr.

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.

Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy

Prospective, Multicenter, Single-arm Study on the Performance of Symmcora® Long-term Bidirectional Barbed Suture for Vesicourethral Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy.

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 16 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 13 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

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.

Blood loss is estimated by the amount of intraoperatively needed transfusion

Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag

Urinary retention is an inability to completely empty the bladder

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.

Cumulative rate of patients with a complication related to the bladder neck contracture

Cumulative rate of patients with a complication related to urinary stone formation

Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)

Time to perform the intervention from first cut to last cut of the last thread. The time is measured using a stopwatch.

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.

Number of days from surgery till patient is discharged from hospital

Number of days from surgery till catheter was finally removed

Days after catheter was finally removed to complete continence

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.

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).

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG

Spots Global Cancer Trial Database for robot assisted radical prostatectomy