A Pragmatic Randomized Controlled Trial Comparing the Effects of Suturing Techniques for Vesico-urethral Anastomosis on One-year Voiding Function After Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer Surgery
- Sponsor
- Kartal City Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Maximum flow rate (MFR)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Utku Can
Assistant professor of urology
Kartal City Hospital
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
Outcomes
Primary Outcomes
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.
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.
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.
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
- Surgical parameters(During the operation)
- Anastomotic extravasation(Postoperative day 5.)
- Perioperative complications(Through study completion, an average of 1 year)