Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Clinical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients
研究概览
简要总结
Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study we perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients.
The hypothesis is as follows:
- In a "western setting" the somato-sensory reflex arch can be created in adult SCI patients with only minor morbidity and complications.
- Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.
详细描述
Introduction:
Spinal cord injury has a profound impact on the lives of those affected. Quality of life is restricted not only by immobility but also by severe neurogenic bladder and bowel dysfunction. For example, 66% of SCI patients have to empty their rectum digitally, 75% suffer from faecal incontinence and 9% spend more than 60 minutes each time they defecate. Neurological impairment due to SCI is permanent and the average age at injury is only 28 years. The longevity of individuals with SCI is approaching that of the general population and, accordingly, most patients have to live for several decades with severe bladder and bowel symptoms. It is estimated that the number of individuals with SCI in Denmark is 3.000 and each year 10.000 persons in the European Union sustain a SCI. Even though clean intermittent catheterization has successfully reduced mortality due to urinary tract infections or reflux and though several new treatment modalities for neurogenic bowel dysfunction have been introduced, both bladder and bowel dysfunction still rank among the top three causes of impairment of quality of life after SCI.
Somato-sensory reflex arch:
The concept was pioneered by professor Xiao. Animal studies and basic clinical research were performed in the United States and later human clinical studies have been done in Wuhan, China. The surgical procedure principle can briefly be summarized as follows:
All spinal nerves have an anterior efferent root and a posterior afferent root. For the somato-sensory reflex arch (or "Xiao procedure") the posterior (afferent or sensory) root of the 5th lumbar nerve (L5) is kept while the anterior root is cut and anastomosed to the anterior root of a lower segment, usually the third sacral segment (S3). Thereby, a new reflex arch has been created from the skin of the leg through the sensory part of L5 to the spinal cord and further through the anastomosis via S2 or S3 to the bladder and bowel. Strong stimuli at the L5 dermatome, i.e. scratching or electrical stimulation, will then initiate voiding (6,7). Effects of the somato-sensory reflex arch on neurogenic bowel dysfunction have not been studied, but clinical experience indicates that bowel management is substantially facilitated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years of age or above with motoric complete
- •Spinal cord injury medullary level C4-L4
- •Preserved Hamstring reflex (L5)
- •Participation acceptance in verbal and writing
排除标准
- •Respiratory dependent patient Baclofen pump Malignancy in the urinary tract, surgery on the urinary tract, urethral strictures Ileostomy, Colostomy or radiation towards the area Pregnancy, for men planning a pregnancy with their partner
结局指标
主要结局
Urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients
时间窗: 2013 (anticipated)
Prospective study of urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients.
次要结局
- Colorectal transit times and rectal wall properties after somato-autonomic reflex arch in spinal cord injury patient(2013 (anticipated))
- Colorectal symptoms before and after somato-autonomic reflex arch in spinal cord injury patients(2013 (anticipated))
- Effect of quality of Life after somato-autonomic reflex arch in spinal cord injury patient(2013 (anticipated))
