NCT02517853已完成不适用
Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 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
结局指标
主要结局
Tibial nerve stimulation efficacy measured by LARS score
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Posterior Tibial Nerve Stimulation for Children With Pelvic Floor DyssynergiaFecal Incontinence in ChildrenPelvic Floor DyssynergiaConstipationNCT06528470Nationwide Children's Hospital40
已完成
不适用
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in HomeOveractive BladderNCT03595215Theranova, L.L.C.18
Unknown
不适用
Tibial Nerve Stimulation for Faecal IncontinenceFecal IncontinenceNCT00530933London North West Healthcare NHS Trust66
终止
1 期
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal IncontinenceFecal IncontinenceNCT01666405Uroplasty, Inc30
Unknown
不适用
To Study and Evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for Post-operative Pain in Cesarean Section Patients Using Primary Relief v 2.0Cesarean Section DehiscenceNCT03829774DyAnsys, Inc.22