NCT02425774已完成4 期
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
研究概览
简要总结
Hypothesis:
Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an anti-inflammatory effect.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of prucalopride. The following aims are formulated:
- to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
- to evaluate whether prucalopride leads to accelerated post-operative recovery
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 undergoing partial or full resection of the pancreas due to a benign or malignant tumor
排除标准
- •adjuvant radiotherapy
- •evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory results, including an abscess or cholecystitis)
- •chronic pancreatitis
- •pancreatic polypeptide producing endocrine tumor
- •American Society of Anesthesiologists physical-health status classification (ASA-PS)>3
- •Poorly regulated diabetes (>200 mg/dl (=11 mmol/l))
研究组 & 干预措施
Sham stimulation + Placebo
Placebo Comparator
- no stimulation
- 1 placebo tablet at two different timepoints before surgery
干预措施: Sham stimulation (Procedure)
Sham stimulation + Placebo
Placebo Comparator
- no stimulation
- 1 placebo tablet at two different timepoints before surgery
干预措施: Placebo (Drug)
Vagus stimulation + placebo
Active Comparator
- Stimulation at the beginning and the end of the surgery
- 1 placebo tablet at two different timepoints before surgery
干预措施: Vagus stimulation (Procedure)
Vagus stimulation + placebo
Active Comparator
- Stimulation at the beginning and the end of the surgery
- 1 placebo tablet at two different timepoints before surgery
干预措施: Placebo (Drug)
Prucalopride + sham stimulation
Active Comparator
- 1 prucalopride tablet at two different timepoints before surgery
- no stimulation
干预措施: Sham stimulation (Procedure)
Prucalopride + sham stimulation
Active Comparator
- 1 prucalopride tablet at two different timepoints before surgery
- no stimulation
干预措施: Prucalopride (Drug)
结局指标
主要结局
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
时间窗: From the date of surgery until the date of lab analysis (up to 6 months)
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))
- 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 discharge from the hospital(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))
- Gastrointestinal symptoms (nausea, pain, vomiting, bloating)(From the date of surgery until the date of discharge from the hospital (on average 14 days))
研究者
研究点 (1)
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