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临床试验/NCT02976870
NCT02976870已完成不适用

Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

Nottingham University Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Identification of hydronephrosis on ultrasound scan

研究概览

简要总结

Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient in order to access the spine. During this process, several internal structures are pushed aside in order to gain access. One of these structures is the ureter, whose function is to drain urine from the kidney to the bladder. One potential complication that can arise from this is dilation of the kidney - known as hydronephrosis. The aim of this study is to identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is complication, in order to bring this to the attention of health care professionals when considering this kind of surgery.

详细描述

A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan of their kidney on the side where the operation was performed (where the scar is). Should hydronephrosis of this kidney be detected, the investigators will go on to scan the second kidney. Should hydronephrosis be detected the patient will be given a letter to take to their General Practitioner (GP) advising them to be referred to a Urologist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Over 18 years of age
  • Has the mental capacity to provide informed consent for participation within the study
  • Patients who have had anterior lumbar spinal surgery at least 12 months ago and no longer than 5 years ago

排除标准

  • Unable to understand written or verbal information regarding the study
  • Multiple abdominal surgeries prior to spinal surgery
  • Previous renal complication such as renal strictures or hydronephrosis/use of stents
  • Pregnancy
  • Structural anomalies

结局指标

主要结局

Identification of hydronephrosis on ultrasound scan

时间窗: 12 month

Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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