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

NCT ID: NCT06055946

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2025-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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robot assisted radical prostatectomy barbed suture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symmcora® Long bidirectional

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

robotic assisted radical prostatectomy

Intervention Type DEVICE

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

Interventions

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robotic assisted radical prostatectomy

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Miguel Sánchez Encinas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Rey Juan Carlos

Locations

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Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AAG-O-H-2207

Identifier Type: -

Identifier Source: org_study_id