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

NCT06055946 | Completed

• 1 other identifier: AAG-O-H-2207
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

robot assisted radical prostatectomy; barbed suture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Anastomotic leak rate until 6 months postoperatively

  up to 6 months after surgery

• Amount of estimate blood loss (EBL)

  intraoperatively

• Transfusion rate

  at discharge from hospital (approximately 5-10 days after surgery)

• Urinary retention

  at 6 weeks postoperatively

• Urinary fistula rate

  until 6 months postoperatively

Other Outcomes (2)

• Assessment of the intraoperative handling of the Symmcora® Long bidirectional

  after inclusion of the last patient

• Assessment of the intraoperative handling of the Symmcora® Mid Unidirectional

  after inclusion of the last patient

Study Arms (1)

Symmcora® Long bidirectional

Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.

Device: robotic assisted radical prostatectomy

Interventions

robotic assisted radical prostatectomy DEVICE

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

Symmcora® Long bidirectional

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients undergoing an elective robotic assisted radical prostatectomy

You may qualify if:

• Male patients undergoing an elective robotic assisted radical prostatectomy
• Written informed consent
• Age ≥ 18years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (2)

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dr. Miguel Sánchez Encinas, Dr.

  Hospital Universitario Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 28, 2023
• Study Start: November 7, 2023
• Primary Completion: December 19, 2024
• Study Completion: May 19, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

ES (2)