Clinical trial NCT06670924: Suturing Techniques for Vesico-urethral Anastomosis
Official title: A Pragmatic Randomized Controlled Trial Comparing the Effects of Suturing Techniques for Vesico-urethral Anastomosis on One-year Voiding Function After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Surgery
Keywords: prostate cancer
vesicourethral anastomosis
voiding function
suture
Lead sponsor: Kartal City Hospital
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 70
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum flow rate (MFR)
timeFrame: preoperative and 1,3,6,12 months visits after surgery.
measure: Post-voiding residuel volume (PVR)
timeFrame: preoperative and 1,3,6,12 months visits after surgery.
measure: Urinary function(UF)
timeFrame: preoperative and 1,3,6,12 months visits after surgery.
measure: Continence recovery
timeFrame: preoperative and 1,3,6,12 months visits after surgery.
Secondary outcomes:
measure: Surgical parameters
timeFrame: During the operation
measure: Anastomotic extravasation
timeFrame: Postoperative day 5.
measure: Perioperative complications
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital
Study officials:
affiliation: Kartal Dr Lutfi Kirdar City Hospital
name: Utku Can
role: PRINCIPAL_INVESTIGATOR
References: