InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
研究概览
简要总结
Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.
Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.
A new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).
Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.
The aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •patients > 18 years
- •elective colectomy or proctectomy
- •agreement for the research
排除标准
- •chronic inflammatory bowel disease
- •irritable bowel disease documented
- •history of surgery on oesophagus or stomach
- •acetylcholine dysfunction
- •enterostoma
- •patient holder of pace-maker
研究组 & 干预措施
percutaneous tibial nerve stimulation (ST)
Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.
Stimulation every day (x3) after surgery until gastrointestinal functions recovery.
The protocol of stimulation is the same, that the one performed for fecal incontinence.
干预措施: percutaneous tibial nerve stimulation (Device)
placebo (P)
Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.
Stimulation every day (x3) after surgery until gastrointestinal functions recovery.
The device delivers ineffective impulses.
干预措施: Placebo (Device)
结局指标
主要结局
delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
时间窗: data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)
次要结局
未报告次要终点