Suturing Techniques for Vesico-urethral Anastomosis

NCT ID: NCT06670924

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-08-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Running suture (RS)

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

Group Type: ACTIVE_COMPARATOR

Running suture for vesico-urethral anastomosis in open radical prostatectomy

Intervention Type: 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 (IS)

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

Group Type: ACTIVE_COMPARATOR

interrupted suture for vesico-urethral anastomosis in open radical prostatectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kartal City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Utku Can

Assistant professor of urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Utku Can

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr Lutfi Kirdar City Hospital

Locations

University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

kartalcity_ucan_001

Identifier Type: -

Identifier Source: org_study_id