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临床试验/NCT06248047
NCT06248047尚未招募不适用

Vessel-sparing Technique Versus Conventional Repair of Pelvic Fracture Urethral Injury: A Prospective Comparative Study

Assiut University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Retrograde Urethrogram RUG

研究概览

简要总结

Pelvic fracture is associated with urethral injury in about 10% of patients . The common site of injury is at the bulbomembranous Junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury (PFUI) .

Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury, a maneuver that requires division of the bulbar arteries . Then, the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances .

When the distal blood supply to the urethra is compromised, either by congenital anomalies such a hypospadias, by previous surgery, or by the pre-existing pelvic fracture, the retrograde flow to the spongiosum is insufficient . In such cases, traditional anastomotic urethroplasty may result in ischemic bulbar necrosis, leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter, with subsequent retrograde urethrogram (RUG) showing a long bulbar urethral defect .

In 2007, Jordan et al described a modification to excision and primary anastomosis (EPA) in the proximal bulbar urethral strictures particularly post radical prostatectomy, which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained .

Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal. Consequently, they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow .

So that, we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Adult male patients ≥ 18 years old with PFUI

排除标准

  • Recurrent cases. • History of concomitant bladder neck injury

结局指标

主要结局

Retrograde Urethrogram RUG

时间窗: three months after the operation

contrast study to evaluate and delineate the urethera

UROFLOWMETERY

时间窗: three months after the operation

the speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec

postmicturition residue

时间窗: three months after the operation

abdominal ultrasound done to evaluate PMR

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mena Hosam Mahdy

teaching assistant of urology

Assiut University

研究点 (1)

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