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

Prostate Cancer Clinical Trial

— BARVANA LONG  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055946
• Other study ID #: AAG-O-H-2207
• Status: Recruiting
• Start date: November 7, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Aesculap AG
• Contact: Irene Fita Esteban
• Phone: +34935866200
• Email: info[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Anastomotic leak rate until 6 months postoperatively	Cumulative number of anastomotic leaks	up to 6 months after surgery
Secondary	Amount of estimate blood loss (EBL)	Blood loss is estimated by the amount of intraoperatively needed transfusion	intraoperatively
Secondary	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)
Secondary	Urinary retention	Urinary retention is an inability to completely empty the bladder	at 6 weeks postoperatively
Secondary	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
Secondary	Bladder neck contracture rate	Cumulative rate of patients with a complication related to the bladder neck contracture	until 6 months postoperatively
Secondary	Urinary stone formation rate	Cumulative rate of patients with a complication related to urinary stone formation	until 6 months postoperatively
Secondary	Rate of other complications	Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)	until 6 months postoperatively
Secondary	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
Secondary	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
Secondary	Length of postoperative stay	Number of days from surgery till patient is discharged from hospital	until discharge (approximately 5-10 days postoperatively)
Secondary	Catheterization duration	Number of days from surgery till catheter was finally removed	until first follow-up (6 weeks postoperatively)
Secondary	Early continence	Days after catheter was finally removed to complete continence	6 weeks postoperatively
Secondary	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.
Secondary	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.
Secondary	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 ?ve options for the ?rst 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 classi?ed as mild to severe depending on the total score. Patients having a total score =7 are classi?ed as having mild symptoms, scores from 8 to 19 are classi?ed as moderate symptoms, and symptom scores =20 are classi?ed as severe symptoms.	Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
Secondary	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.