Clinical Trials Directory

Trials / Completed

CompletedNCT06670924

Suturing Techniques for Vesico-urethral Anastomosis

A Pragmatic Randomized Controlled Trial Comparing the Effects of Suturing Techniques for Vesico-urethral Anastomosis on One-year Voiding Function After Radical Prostatectomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Kartal City Hospital · Academic / Other
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

Radical prostatectomy (RP) is the most common curative treatment for prostate cancer (PCa).Vesicourethral anastomosis (VUA) is a crucial step and either a conventional interrupted (IS) or a running (RS) suture is employed during radical prostatectomy (RP). Certainly, both RS and IS have advantages and limitations. The metanalysis revealed that potential advantages for RS compared to IS, especially for short-term outcomes such as catheterization time, extravasation rate, and anastomotic suture time. There were no significant differences for long-term outcomes (continence, incidence of vesicourethral anastomotic stenosis). Generally, the exciting evidence suggests that CS should be preferred over IS. However, this should be followed only if it is technically feasible and appropriate regarding the surgical approach. Both techniques seem to be safe and appropriate for the VUA, and the technique should be chosen based on individual experience and preference. The investigators hypothesized that RS and IS may have different effects on voiding function and flow rate, even if they do not cause an anastomotic stenosis requiring intervention. Furthermore, there is no existing literature that compares RS and IS in terms of voiding function.This article focuses on one year uroflowmetric voiding parameters, urinary function (UF), and UF related bother function, urinary continence recovery as well as other secondary outcomes, including surgical parameters, perioperative morbidity and oncological outcomes.

Conditions

Interventions

TypeNameDescription
PROCEDURERunning suture for vesico-urethral anastomosis in open radical prostatectomyThe surgical technique of the RS followed the description of Van Velthovens, was applied with slight modifications. Two 3/0 absorbable monofilament (polydioxanone) sutures were used. The first needle is started from bladder neck at 3 o'clock, and terminated in the urethra at 9 o'clock. After completion of the posterior anastomosis, a transurethral catheter is placed. The second sutures' needle is passed from the bladder at 9 o'clock and ended in the urethra at 3 o'clock. The bladder neck and urethra are merged by gentle traction of the anterior and posterior sutures at 3 and 9 o'clock.
PROCEDUREinterrupted suture for vesico-urethral anastomosis in open radical prostatectomyThe technique described by Walsh for interrupted anastomotic suturing was applied with minor modifications. Six 3/0 absorbable monofilament (polydioxanone) sutures were placed at 1, 3, 5, 7, 9 and 11 o'clock to accomplish the vesicourethral anastomosis.

Timeline

Start date
2022-02-07
Primary completion
2023-08-01
Completion
2024-08-16
First posted
2024-11-01
Last updated
2024-11-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06670924. Inclusion in this directory is not an endorsement.