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临床试验/NCT06670924
NCT06670924已完成不适用

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

Kartal City Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Maximum flow rate (MFR)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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.

入排标准

性别
Male
接受健康志愿者
否

入选标准

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

排除标准

  • •History of acute urinary retention
  • •History of urethral stricture

研究组 & 干预措施

Running suture (RS)

Active Comparator

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

干预措施: Running suture for vesico-urethral anastomosis in open radical prostatectomy (Procedure)

Interrupted suture (IS)

Active Comparator

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

干预措施: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy (Procedure)

结局指标

主要结局

Maximum flow rate (MFR)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

  • Surgical parameters(During the operation)
  • Anastomotic extravasation(Postoperative day 5.)
  • Perioperative complications(Through study completion, an average of 1 year)

研究者

发起方
Kartal City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Utku Can

Assistant professor of urology

Kartal City Hospital

研究点 (1)

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