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临床试验/NCT03195179
NCT03195179已完成不适用

The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

University of Utah1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Urethral obstruction

研究概览

简要总结

Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial urethral realignment after PFUI decreases rates of urethral obstruction and the need for subsequent urethral procedures.

The retrospective record review should determine the utility of acute urethral realignment after PFUI.

详细描述

A retrospective chart review to compare outcomes between urethral realignment (group 1) and suprapubic tube (SPT) placement (group 2). The comparison will be between two routinely practiced management approaches of urethral injury after pelvic fracture.

Prior studies demonstrate urethral realignment is associated with a 15% to 50% reduction in urethral obstruction, however, it has also been associated with higher rates of incontinence and erectile dysfunction. Our hypothesis is that early realignment of traumatic urethral injuries after pelvic fracture lowers the incidence of complications like urethral strictures and subsequent need for surgeries.

研究设计

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

入排标准

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

入选标准

  • Men > 18 years old Blunt force trauma Presence of pelvic fracture Urethral injury Inability to pass a Foley catheter retrograde through the injury into the bladder

排除标准

  • Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion

结局指标

主要结局

Urethral obstruction

时间窗: Through study completion, an average of 1 year

Rates of urethral obstruction identified by urethrogram or cystoscopy

次要结局

  • Urethroplasty complexity - gap length during urethroplasty(Through study completion, an average of 1 year)
  • Urethroplasty complexity - bulbar mobilization length during urethroplasty(Through study completion, an average of 1 year)
  • Urethroplasty complexity - urethral fistula present(Through study completion, an average of 1 year)
  • Urethroplasty complexity - total obstruction of the urethra during urethroplasty(Through study completion, an average of 1 year)
  • Treatment rate for urethral obstruction(Through study completion, an average of 1 year)
  • Urethroplasty complexity - corporal splitting during urethroplasty(Through study completion, an average of 1 year)
  • Urethroplasty complexity - total pubectomy during urethroplasty(Through study completion, an average of 1 year)
  • Urethroplasty complexity - inferior pubectomy during urethroplasty(Through study completion, an average of 1 year)
  • Erectile function - medical treatment rates(Through study completion, an average of 1 year)
  • Urethroplasty complexity - urethral diverticulum discovered during urethroplasty(Through study completion, an average of 1 year)
  • Erectile function- SHIM score(Through study completion, an average of 1 year)
  • Erectile function - surgical treatment rates(Through study completion, an average of 1 year)
  • Post-injury complications(3 month period post acute urethral injury)
  • Incontinence(Through study completion, an average of 1 year)

研究者

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

Jeremy Myers

Associate Professor

University of Utah

研究点 (1)

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