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临床试验/NCT04079673
NCT04079673已完成不适用

The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年10月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Microbiota analysis

研究概览

简要总结

As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.

The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.

Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.

排除标准

  • Previous use of antibiotics within four weeks.
  • Previous gastrointestinal surgery.

研究组 & 干预措施

Patient controlled epidural analgesia

Active Comparator

Use of patient controlled epidural analgesia (PCEA) for postoperative pain control

干预措施: Patient controlled epidural analgesia (Procedure)

Intravenous patient controlled analgesia

Sham Comparator

Use of intravenous patient controlled analgesia(IVPCA) for postoperative pain control

干预措施: Intravenous patient controlled analgesia (Drug)

结局指标

主要结局

Microbiota analysis

时间窗: one month

16S metagenomic sequence processing

次要结局

  • IL-6(one month)
  • LPS-binding protein(one month)
  • IgA(one month)
  • Intestinal fatty acid binding protein(one month)
  • I-FEED scoring(one week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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