Clinical trial · Observational
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robotic assisted radical prostatectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symmcora® Long bidirectional
- description
- Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.
- interventionNames
- Device: robotic assisted radical prostatectomy
Primary outcomes (1)
- measure
- Time to perform the vesicourethral anastomosis
- timeFrame
- intraoperatively
- description
- 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 outcomes (17)
- measure
- Anastomotic leak rate until 6 months postoperatively
- timeFrame
- up to 6 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available