Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Distance lead to nerve
研究概览
简要总结
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
详细描述
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.
The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cadaver study
- •All of these individuals had donated their bodies to medical education and research in form of an informed consent.
排除标准
- 未提供
结局指标
主要结局
Distance lead to nerve
时间窗: 1 week
The exact distance (mm) will be assessed from the lead to the nerve
次要结局
- Neuroforamen(1 week)
- Sacral fascia(1 week)
研究者
Dr. Christopher Dawoud
Dr.med.univ.
Medical University of Vienna