NCT02524626已完成3 期
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The gastrointestinal transit (geometric mean)
研究概览
简要总结
Hypothesis:
Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery.
Aims:
In the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. In addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To this end, the following aims are formulated:
- to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 with ovarium, pancreas or colorectal carcinoma eligible for resection
排除标准
- •preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
- •evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis)
- •American Society of Anesthesiologists physical-health status classification (ASA-PS) > 3
- •poorly regulated diabetes (> 200 mg/dl (= 11 mmol/l)
- •surgery due to chronic pancreatitis
研究组 & 干预措施
Sham stimulation
Sham Comparator
no stimulation of vagus nerve
干预措施: Sham stimulation (Procedure)
Vagus stimulation
Active Comparator
Stimulation of the vagus nerve at the beginning and the end of the surgery
干预措施: Vagus stimulation (Procedure)
结局指标
主要结局
The gastrointestinal transit (geometric mean)
时间窗: From postoperative day 3 until postoperative day 7
次要结局
- Time to first flatus(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Gastrointestinal symptoms (nausea, pain, vomiting, bloating)(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1(From the date of surgery until postoperative day 1)
- Time to tolerance of oral food intake and first defecation(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Time to first defecation(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Time to tolerance of oral food intake(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Time to discharge from the hospital(From the date of surgery until the date of discharge from the hospital (on average 14 days))
- Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood(From the date of surgery until the date of lab analysis (up to 6 months))
研究者
研究点 (1)
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