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

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.

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: robotic assisted radical prostatectomy

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid
    • Móstoles, Madrid, Spain, 28933
      • Hospital Universitario Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients undergoing an elective robotic assisted radical prostatectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symmcora® Long bidirectional; Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.	Device: robotic assisted radical prostatectomy; Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Dr. Miguel Sánchez Encinas, Dr., Hospital Universitario Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): May 19, 2025

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: barbed suture; robot assisted radical prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AAG-O-H-2207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No