Prostate CancerBARVANA LONGNCT06055946
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy
An observational study of Prostate Cancer, run by Aesculap AG at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- robotic assisted radical prostatectomy
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Nov 2023to 19 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients undergoing an elective robotic assisted radical prostatectomy
Who may be able to join
- Male patients undergoing an elective robotic assisted radical prostatectomy
- Written informed consent
- Age ≥ 18years
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
About this study
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.
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.
- Conditions
- Prostate Cancer
- Being tested
- robotic assisted radical prostatectomy
- Keywords
- robot assisted radical prostatectomy, barbed suture
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic assisted radical prostatectomyDevice
Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study
| Study group | Role | What they receive |
|---|---|---|
| Symmcora® Long bidirectional | Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy. Receives: Device: robotic assisted radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperatively
Secondary outcomes (17)
Anastomotic leak rate until 6 months postoperatively
Cumulative number of anastomotic leaks
Measured: up to 6 months after surgery
Amount of estimate blood loss (EBL)
Blood loss is estimated by the amount of intraoperatively needed transfusion
Measured: intraoperatively
Transfusion rate
Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag
Measured: at discharge from hospital (approximately 5-10 days after surgery)
Urinary retention
Urinary retention is an inability to completely empty the bladder
Measured: 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.
Measured: until 6 months postoperatively
Bladder neck contracture rate
Cumulative rate of patients with a complication related to the bladder neck contracture
Measured: until 6 months postoperatively
Urinary stone formation rate
Cumulative rate of patients with a complication related to urinary stone formation
Measured: until 6 months postoperatively
Rate of other complications
Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)
Measured: 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.
Measured: 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.
Measured: intraoperatively
Length of postoperative stay
Number of days from surgery till patient is discharged from hospital
Measured: until discharge (approximately 5-10 days postoperatively)
Catheterization duration
Number of days from surgery till catheter was finally removed
Measured: until first follow-up (6 weeks postoperatively)
Early continence
Days after catheter was finally removed to complete continence
Measured: 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.
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).
Measured: 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.
Measured: 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
Measured: at screening and 6 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start7 Nov 2023
- Primary completion19 Dec 2024
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Dr. Miguel Sánchez Encinas, Dr., Principal investigator, Hospital Universitario Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055946
- Sponsor's protocol ID
- AAG-O-H-2207
- Acronym
- BARVANA LONG
- Status last verified
- Dec 2025
- First submitted
- 6 Sep 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06055946
- Acronym / sponsor ID
- BARVANA LONG / AAG-O-H-2207
- Conditions
- Prostate Cancer
- Keywords
- robot assisted radical prostatectomy, barbed suture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symmcora® Long bidirectional | – | Device: robotic assisted radical prostatectomySymmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients undergoing an elective robotic assisted radical prostatectomy
Key inclusion criteria (3 listed)
- Male patients undergoing an elective robotic assisted radical prostatectomy
- Written informed consent
- Age ≥ 18years
Key exclusion criteria (7 listed)
- Emergency surgery
- History of chronic steroid use
- Previous prostatic surgery
- Previous radiotherapy or brachytherapy
- Patients with hypersensitivity or allergy to the suture material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic assisted radical prostatectomyAdult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study | Device | Symmcora® Long bidirectional |
Primary outcome
Time to perform the vesicourethral anastomosis
Time frame: 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.
17 secondary outcomes
Anastomotic leak rate until 6 months postoperatively
Time frame: up to 6 months after surgery
Amount of estimate blood loss (EBL)
Time frame: intraoperatively
Transfusion rate
Time frame: at discharge from hospital (approximately 5-10 days after surgery)
Urinary retention
Time frame: at 6 weeks postoperatively
Urinary fistula rate
Time frame: until 6 months postoperatively
Bladder neck contracture rate
Time frame: until 6 months postoperatively
Urinary stone formation rate
Time frame: until 6 months postoperatively
Rate of other complications
Time frame: until 6 months postoperatively
Operation consola time
Time frame: intraoperatively
Time to perform the Rocco stitch
Time frame: intraoperatively
Length of postoperative stay
Time frame: until discharge (approximately 5-10 days postoperatively)
Catheterization duration
Time frame: until first follow-up (6 weeks postoperatively)
Early continence
Time frame: 6 weeks postoperatively
Development of continence by 24-h pad test
Time frame: at 3 months and 6 months postoperatively.
Development of Erectile Function compared to baseline
Time frame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
Development of International prostate symptom score (IPSS) compared to baseline
Time frame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
Comparison of Prostate Specific Antigen (PSA) at screening and 6 weeks after surgery.
Time frame: at screening and 6 weeks after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Miguel Sánchez Encinas, Dr. principal investigator
Hospital Universitario Rey Juan Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Aesculap AG at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to perform the vesicourethral anastomosis (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.