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Clinical Trials/NCT04079673
NCT04079673CompletedNot Applicable

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

National Taiwan University Hospital2 sites in 1 country42 target enrollmentStarted: October 19, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Microbiota analysis

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Patient controlled epidural analgesia

Active Comparator

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

Intervention: Patient controlled epidural analgesia (Procedure)

Intravenous patient controlled analgesia

Sham Comparator

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

Intervention: Intravenous patient controlled analgesia (Drug)

Outcomes

Primary Outcomes

Microbiota analysis

Time Frame: one month

16S metagenomic sequence processing

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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