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临床试验/NCT04483570
NCT04483570已完成不适用

Urological Deterioration in Secondary Tethered Cord Syndrome and Clue to Detect It

Seoul National University Hospital0 个研究点目标入组 54 人开始时间: 2011年1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
54
主要终点
Pre-operative evaluation: Dysfunctional voiding

研究概览

简要总结

Secondary tethered cord syndrome (STCS) has been diagnosed with signs of progressive deterioration in urological or neuroorthopedic systems following primary tethering surgery. However, there is no convincing urological diagnostic clue for STCS.

详细描述

Tethered cord syndrome (TCS) refers to various problems involving neurologic, orthopedic, and urologic systems, seen as a result of chronic traction of the spinal cord in patients with spinal dysraphism. Evidence for neural injury is often assumed irreversible, so untethering is justified to maintain neural function and prevent further neural damage. Unfortunately, some patients experienced an aggravation of symptoms following untethering. The probable causes are assumed to be the neural injury before or during operation, which was revealed along with dysplastic neural function, neural compression by increasing syrinx and secondary tethered cord syndrome (STCS) in which postoperative neural adhesion or syrinx limit motion of spinal and elicit ischemic changes as the spine grows during puberty. The Secondary Tethered Cord Syndrome is reported as 19% of cases and causes significant progressive morbidities in those who affected.

Unfortunately, the detection of STCS is not as simple as it thought. Although magnetic resonance imaging (MRI) often reveals that the cord seems to get straightened, this does not necessarily mean that is a significant tethering or cord associated with progressive nerve damage. The variable course of progression and involvement of multiple systems such as lower extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions about the presence of secondary tethered cord syndrome. Moreover, the untethering procedure of STCS may not always be safe and effective. Given the fact that a significant number of 'no improvement' or new onset complications following redo-untethering, the surgery could not be attempted without clear evidence. This explains the reason there is only a limited number of relevant studies so far.

In this study, it aims to delinate the genuine features of secondary tethered cord syndrome by selecting and analyzing only cases with symptom improvements. Furthermore, it described their natural history and time course of urological deterioration and characterized by the urodynamic changes before and after the redo-untethering.

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
3 Months 至 23 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with signs of progressive deterioration in urological or neuroorthopedic system following primary untethering surgery.

排除标准

  • Children without signs of progressive in urological or neuroorthopedic system following primary untethering surgery.

结局指标

主要结局

Pre-operative evaluation: Dysfunctional voiding

时间窗: Baseline

Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation.

Pre-operative evaluation: Presence of Urinary Tract Infection (UTI)

时间窗: Baseline

Evaluating any presence of urinary and fecal incontinence before the secondary tethered cord syndrome operation

VUD (Video Urodynamic Studies)

时间窗: 2 years after the operation

Measuring changes in maximal cystometric capacity, compliance, estimated bladder after the operation of the secondary tethered cord syndrome

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

Kwanjin Park

Associate Professor

Seoul National University Hospital

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