Suturing Techniques for Vesico-urethral Anastomosis

NCT06670924 | Completed

• 1 other identifier: kartalcity_ucan_001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer Surgery

Keywords

prostate cancer; vesicourethral anastomosis; voiding function; suture

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Surgical parameters

  During the operation

• Anastomotic extravasation

  Postoperative day 5.

• Perioperative complications

  Through study completion, an average of 1 year

Study Arms (2)

Running suture (RS)

ACTIVE COMPARATOR

Running suture technique for vesico-urethral anastomosis in open radical prostatectomy

Procedure: Running suture for vesico-urethral anastomosis in open radical prostatectomy

Interrupted suture (IS)

ACTIVE COMPARATOR

Interrupted suture technique for vesico-urethral anastomosis in open radical prostatectomy

Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy

Interventions

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.

Running suture (RS)

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.

Interrupted suture (IS)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of acute urinary retention
• History of urethral stricture

Sponsors & Collaborators

• Kartal City Hospital: lead

Study Sites (1)

University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Utku Can

  Kartal Dr Lutfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Data were collected by an independent database administrator and stored in a password-protected Microsoft Excel file. The data files were not accessible to the surgical team or to residents or ancillary staff involved in postoperative care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of urology

Model Details: The investigators conducted a two-group, parallel-design, pragmatic study of 70 consecutive patients with clinically localised (pT1-pT2) PCa undergoing primary open RP by a well-experienced single surgical team at Dr Lutfi Kirdar City Hospital as a tertiary care institution .The optimal sample size for this study was calculated to be 70 patients (35 patients in each arm) by the power calculation (α = 0.05, β = 0.1, power: 90%) The subjects were randomly assigned to one of two treatment groups using a simple randomization procedure that involved computer-generated random numbers in Microsoft Excel.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: February 7, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 16, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)