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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: robotic assisted radical prostatectomy

• Registration Number: NCT06055946
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-28
• Study Start: 2023-11-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

• Male patients undergoing an elective robotic assisted radical prostatectomy
• Written informed consent
• Age ≥ 18years

Exclusion Criteria

• Emergency surgery
• History of chronic steroid use
• Previous prostatic surgery
• Previous radiotherapy or brachytherapy
• Patients with hypersensitivity or allergy to the suture material.
• Participation in another study
• Non-compliant patient (dementia etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to perform the vesicourethral anastomosis	intraoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Amount of estimate blood loss (EBL)	intraoperatively	Blood loss is estimated by the amount of intraoperatively needed transfusion
Anastomotic leak rate until 6 months postoperatively	up to 6 months after surgery	Cumulative number of anastomotic leaks
Transfusion rate	at discharge from hospital (approximately 5-10 days after surgery)	Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag
Urinary fistula rate	until 6 months postoperatively	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.
Rate of other complications	until 6 months postoperatively	Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)
Operation consola time	intraoperatively	Time to perform the intervention from first cut to last cut of the last thread. The time is measured using a stopwatch.
Urinary retention	at 6 weeks postoperatively	Urinary retention is an inability to completely empty the bladder
Bladder neck contracture rate	until 6 months postoperatively	Cumulative rate of patients with a complication related to the bladder neck contracture
Urinary stone formation rate	until 6 months postoperatively	Cumulative rate of patients with a complication related to urinary stone formation
Development of Erectile Function compared to baseline	Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.	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).
Early continence	6 weeks postoperatively	Days after catheter was finally removed to complete continence
Time to perform the Rocco stitch	intraoperatively	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.
Catheterization duration	until first follow-up (6 weeks postoperatively)	Number of days from surgery till catheter was finally removed
Development of continence by 24-h pad test	at 3 months and 6 months postoperatively.	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.
Length of postoperative stay	until discharge (approximately 5-10 days postoperatively)	Number of days from surgery till patient is discharged from hospital
Development of International prostate symptom score (IPSS) compared to baseline	Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.	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.
Comparison of Prostate Specific Antigen (PSA) at screening and 6 weeks after surgery.	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

Trial Locations

Locations (2)

Hospital Universitario Rey Juan Carlos; 🇪🇸 Móstoles, Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain