An interventional study of Running suture for vesico-urethral anastomosis in open radical prostatectomy and interrupted suture for vesico-urethral anastomosis in open radical prostatectomy in Prostate Cancer Surgery, sponsored by Kartal City Hospital. Completed at 1 site in Turkey. Open to male participants. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Kartal City Hospital · Not applicable, Interventional, and Treatment
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.
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Running suture technique for vesico-urethral anastomosis in open radical prostatectomy
Procedure: Running suture for vesico-urethral anastomosis in open radical prostatectomy
Interrupted suture technique for vesico-urethral anastomosis in open radical prostatectomy
Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy
The 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.
The 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.
Maximum flow rate (MFR)
Uroflowmetry is a noninvasive test that measures the rate of urine flow over time. Uroflowmetry involves a well-hydrated patient voiding into a uroflowmeter, which in turn generates a "flow curve." The flow curve enables the measurement of the MFR .A value of 15ml/sec or below is deemed to be outside the normal range.
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Post-voiding residuel volume (PVR)
PVR is defined as the residual urine volume in the bladder following voiding, as calculated by ultrasound imaging. A volume of 150 cc or above is regarded as pathological.
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Urinary function(UF)
Urinary function(UF) and urinary function-related bother: UF measured by the International Prostate Symptom Score \[IPSS\]) The IPSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 . UF-related bother measured by the IPSS quality of life question with a response from 0 to 6.
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Continence recovery
Urinary continence recovery defined as patient-reported use of zero pad or one security pad per day.
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Surgical parameters
Duration of vesico-urethral anastomosis time
Time frame: During the operation
Anastomotic extravasation
Presence of anastomotic extravasation on first cystogram
Time frame: Postoperative day 5.
Perioperative complications
Clavien-Dindo scoring system
Time frame: Through study completion, an average of 1 year
Plan to share: No
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