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

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Aesculap

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: robotic assisted radical prostatectomy

Study type

Observational

Funder types

Industry

Identifiers

NCT06055946
AAG-O-H-2207

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

70 participants in 1 patient group

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

Trial contacts and locations

2

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Central trial contact

Irene Fita Esteban; Anna Ibañez Jimenez

Data sourced from clinicaltrials.gov

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