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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symmcora® Long bidirectional | Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic assisted radical prostatectomy | Device | Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate until 6 months postoperatively | Cumulative number of anastomotic leaks | up to 6 months after surgery |
| Amount of estimate blood loss (EBL) | Blood loss is estimated by the amount of intraoperatively needed transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the intraoperative handling of the Symmcora® Long bidirectional | 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) | after inclusion of the last patient |
Inclusion Criteria:
Exclusion Criteria:
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Male patients undergoing an elective robotic assisted radical prostatectomy
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Miguel Sánchez Encinas, Dr. | Hospital Universitario Rey Juan Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Rey Juan Carlos | Móstoles | Madrid | 28933 | Spain | ||
| Hospital General Universitario Gregorio Marañón |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| intraoperatively |
| Transfusion rate | Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag | at discharge from hospital (approximately 5-10 days after surgery) |
| Urinary retention | Urinary retention is an inability to completely empty the bladder | 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. | until 6 months postoperatively |
| Bladder neck contracture rate | Cumulative rate of patients with a complication related to the bladder neck contracture | until 6 months postoperatively |
| Urinary stone formation rate | Cumulative rate of patients with a complication related to urinary stone formation | until 6 months postoperatively |
| Rate of other complications | Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.) | 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. | 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. | intraoperatively |
| Length of postoperative stay | Number of days from surgery till patient is discharged from hospital | until discharge (approximately 5-10 days postoperatively) |
| Catheterization duration | Number of days from surgery till catheter was finally removed | until first follow-up (6 weeks postoperatively) |
| Early continence | Days after catheter was finally removed to complete continence | 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. | 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). | 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. | 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 | at screening and 6 weeks after surgery. |
| Assessment of the intraoperative handling of the Symmcora® Mid Unidirectional | 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) | after inclusion of the last patient |
| Madrid |
| 28007 |
| Spain |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |