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Completed

NCT Number: NCT06670924

Suturing Techniques for Vesico-urethral Anastomosis

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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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Running suture for vesico-urethral anastomosis in open radical prostatectomy

Procedure

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.

interrupted suture for vesico-urethral anastomosis in open radical prostatectomy

Procedure

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.

Primary outcomes

  1. Maximum flow rate (MFR)

    Time frame: preoperative and 1,3,6,12 months visits after surgery.

    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.

  2. Post-voiding residuel volume (PVR)

    Time frame: preoperative and 1,3,6,12 months visits after surgery.

    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.

  3. Urinary function(UF)

    Time frame: preoperative and 1,3,6,12 months visits after surgery.

    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.

  4. Continence recovery

    Time frame: preoperative and 1,3,6,12 months visits after surgery.

    Urinary continence recovery defined as patient-reported use of zero pad or one security pad per day.

Secondary outcomes

  1. Surgical parameters

    Time frame: During the operation

    Duration of vesico-urethral anastomosis time

  2. Anastomotic extravasation

    Time frame: Postoperative day 5.

    Presence of anastomotic extravasation on first cystogram

  3. Perioperative complications

    Time frame: Through study completion, an average of 1 year

    Clavien-Dindo scoring system

Sponsors and collaborators

Lead sponsor

Kartal City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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