Using a special suture technique during robotic prostate surgery
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.
This study is testing a new type of suture to see if it can make robotic prostate surgery faster and safer for men having the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 2 sites (Móstoles, Madrid and 1 other locations) |
| Trial ID | NCT06055946 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the Symmcora® Long-term bidirectional barbed suture in performing vesicourethral anastomosis during robotic assisted radical prostatectomy. The study will compare the time taken to complete this procedure using the new suture technique against existing literature data, while monitoring for any increase in complication rates. Male patients aged 18 and older who are undergoing elective surgery will be included, provided they meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 18 and older scheduled for elective robotic assisted radical prostatectomy.
Not a fit: Patients who may not benefit from this study include those requiring emergency surgery or those with a history of previous prostate surgery or certain medical conditions.
Why it matters
Potential benefit: If successful, this approach could lead to faster surgical procedures and improved outcomes for patients undergoing prostate cancer surgery.
How similar studies have performed: Other studies have shown promising results with similar suture techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Móstoles, Madrid and 1 other locations
- Hospital Universitario Rey Juan Carlos — Móstoles, Madrid, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Dr. Miguel Sánchez Encinas, Dr. — Hospital Universitario Rey Juan Carlos
- Study coordinator: Irene Fita Esteban
- Email: info@bbraun.com
- Phone: +34935866200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.