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临床试验/NCT04645264
NCT04645264终止不适用

Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar Interbody Fusions

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Length of Hospital Stay

研究概览

简要总结

To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after transforaminal lumbar interbody fusions (TLIFs).

详细描述

Post-operative urinary retention (POUR) is one the most common post-operative complications after elective spine surgeries. Common causes of postoperative urinary retention (POUR) include bladder stenosis, distension, trauma due to catheterizations, age, and prostate hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.

This condition has been associated with the development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly variable, and there is no consensus on effective methods of prevention. We set out to assess POUR from patients catheterized compared to non-catheterized following a transforaminal lumbar interbody fusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis)
  • Patients able to provide informed consent

排除标准

  • Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol
  • Lack of consent

结局指标

主要结局

Length of Hospital Stay

时间窗: Date of surgery until the date of hospital discharge, up to 1 month

How long was the patients post-operative stay?

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

Carla Edwards

Clinical Research Manger

Rush University Medical Center

研究点 (2)

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