Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
研究概览
简要总结
Hypothesis:
Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated:
- to optimize the technique of intra-operative electrical vagus nerve stimulation
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rectal carcinoma eligible for open rectal resection
- •Age between 18 and 70 years
排除标准
- •Preoperative therapeutic abdominal radiation
- •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 (=11mmol/l))
研究组 & 干预措施
Sham stimulation
No stimulation of nervus vagus
Vagus stimulation 1
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
干预措施: Vagus stimulation 1 (Procedure)
Vagus stimulation 2
2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA
干预措施: Vagus stimulation 2 (Procedure)
结局指标
主要结局
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
时间窗: From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery.
次要结局
- gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)(From date of surgery until postoperative day 1.)
- time to tolerance of oral food intake(From date of surgery until the date of discharge from the hospital)
- Time to first defecation(From date of surgery until the date of discharge from the hospital.)
- time to first flatus(From date of surgery until the date of discharge from the hospital.)
- time to tolerance of oral food intake AND first defecation(From date of surgery until the date of discharge from the hospital)
- gastrointestinal symptoms (nausea, pain, bloating)(From date of surgery until the date of discharge from the hospital)