Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Tibial nerve stimulation efficacy measured by LARS score
研究概览
简要总结
The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior Tibial Nerve for the treatment of this syndrome.
A multicentric, prospective, randomized study will be performed in patients affected with severe LARS symptoms. Patients will be randomized in two groups:
- Control group- placebo
- Treatment group: neuroestimulation of the posterior tibial nerve
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 and under 75 years who have been undergone anterior resection of the rectum with sphincter preservation for rectal cancer
- •Patients with LARS score > 29
排除标准
- •Patient with intestinal inflammatory disease
- •Patients with known irritable colon disease
- •Pregnancy patients
- •Patients with others intestinal resection segments different from the rectum
- •Patients with metastatic disease
- •Patient with previous history of posterior tibial neurostimulation or sacral nerve stimulation
研究组 & 干预措施
Tibial nerve stimulation
Tibial nerve stimulation during 16 sessions
干预措施: Posterior tibial nerve stimulation (Device)
Sham comparator
Sham tibial nerve stimulation during 16 sessions
干预措施: Sham posterior tibial nerve stimulation (Device)
结局指标
主要结局
Tibial nerve stimulation efficacy measured by LARS score
时间窗: 12 months
Tibial nerve stimulation efficacy measured by LARS score
时间窗: 1 month
Tibial nerve stimulation efficacy measured by LARS score
时间窗: 3 months
Tibial nerve stimulation efficacy measured by LARS score
时间窗: 6 months
次要结局
未报告次要终点