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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer Surgery
• Intervention / Treatment: Procedure: Running suture for vesico-urethral anastomosis in open radical prostatectomy; Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34865
    • University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of clinically localised (pT1-pT2) prostate cancer
• must select the open radical prostatectomy procedure as a treatment option.

Exclusion Criteria:

• History of acute urinary retention
• History of urethral stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Running suture (RS); Running suture technique for vesico-urethral anastomosis in open radical prostatectomy	Procedure: Running 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.
Active Comparator: Interrupted suture (IS); Interrupted suture technique for vesico-urethral anastomosis in open radical prostatectomy	Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	preoperative and 1,3,6,12 months visits after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical parameters	Duration of vesico-urethral anastomosis time	During the operation
Anastomotic extravasation	Presence of anastomotic extravasation on first cystogram	Postoperative day 5.
Perioperative complications	Clavien-Dindo scoring system	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Kartal City Hospital
• Investigators: Principal Investigator: Utku Can, Kartal Dr Lutfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; suture; voiding function; vesicourethral anastomosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: kartalcity_ucan_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No