Clinical trial NCT06055946: Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: robot assisted radical prostatectomy
barbed suture
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-09-28
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients undergoing an elective robotic assisted radical prostatectomy

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.


Eligibility 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)

Primary outcomes:
measure: Time to perform the vesicourethral anastomosis
timeFrame: intraoperatively
Secondary outcomes:
measure: Anastomotic leak rate until 6 months postoperatively
timeFrame: up to 6 months after surgery
measure: Amount of estimate blood loss (EBL)
timeFrame: intraoperatively
measure: Transfusion rate
timeFrame: at discharge from hospital (approximately 5-10 days after surgery)
measure: Urinary retention
timeFrame: at 6 weeks postoperatively
measure: Urinary fistula rate
timeFrame: until 6 months postoperatively
measure: Bladder neck contracture rate
timeFrame: until 6 months postoperatively
measure: Urinary stone formation rate
timeFrame: until 6 months postoperatively
measure: Rate of other complications
timeFrame: until 6 months postoperatively
measure: Operation consola time
timeFrame: intraoperatively
measure: Time to perform the Rocco stitch
timeFrame: intraoperatively
measure: Length of postoperative stay
timeFrame: until discharge (approximately 5-10 days postoperatively)
measure: Catheterization duration
timeFrame: until first follow-up (6 weeks postoperatively)
measure: Early continence
timeFrame: 6 weeks postoperatively
measure: Development of continence by 24-h pad test
timeFrame: at 3 months and 6 months postoperatively.
measure: Development of Erectile Function compared to baseline
timeFrame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
measure: Development of International prostate symptom score (IPSS) compared to baseline
timeFrame: Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.
measure: Comparison of Prostate Specific Antigen (PSA) at screening and 6 weeks after surgery.
timeFrame: at screening and 6 weeks after surgery.
Other outcomes:
measure: Assessment of the intraoperative handling of the Symmcora® Long bidirectional
timeFrame: after inclusion of the last patient
measure: Assessment of the intraoperative handling of the Symmcora® Mid Unidirectional
timeFrame: after inclusion of the last patient
Locations:
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Hospital Universitario Rey Juan Carlos
name: Dr. Miguel Sánchez Encinas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: