Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

Overview

Laparoscopic cholecystectomy (LC) is widely used in the gallbladder stone, gallbladder polyp, gallbladder cancer and other diseases. Some of the patients would develop diarrhea after surgery, and studies have reported an increased risk of colorectal cancer after LC. The aim of the present study was to examine the effects of LC on the gut microbiota.

Full Title of Study: “Analysis by High-throughput Sequencing: the Impact of Cholecystectomy on Gut Microbiome in Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 20, 2019

Interventions

  • Procedure: Laparoscopic cholecystectomy
    • A special catheter was inserted into the peritoneal cavity, and then about 2-5 liters of carbon dioxide was injected. After reaching a certain pressure, four small holes of 0.5-1.5cm were opened in the abdomen to dissect the structure of the triangle of the gallbladder. The gallbladder duct and gallbladder artery were cut off and closed, and then the entire gallbladder was removed.

Arms, Groups and Cohorts

  • Experimental: Laparoscopic cholecystectomy
    • A laparoscopic cholecystectomy was performed to remove the gallbladder

Clinical Trial Outcome Measures

Primary Measures

  • Change of gut microbiota after laparoscopic cholecystectomy
    • Time Frame: Three months and one year after completion of LC
    • Three months and one year after completion of laparoscopic cholecystectomy therapy, gut microbiota was assessed by 16S rDNA high-throughput sequencing.

Participating in This Clinical Trial

Inclusion Criteria

1. Gallbladder polyps diameter mm >10; 2. The history of the symptoms of patients with gallbladder stones, there was no history of acute attack in the past month; 3. Age <70 years old; 4. No serious systemic diseases such as diabetes, hypertension, heart disease, lung disease and so on/American anesthesia Association (ASA) grade I or II; 5. BMI<30; 6. Families have better care and observation, and away from the hospital within 1 hours; patients and their families understand the process of ambulatory surgery (24 hours) and the pros and cons. Exclusion Criteria:

1. Less than 18 years old; 2. With previous gastric surgery ; 3. Major systemic diseases ; 4. Pregnancy or lactation; 5. The use of antibiotics or yogurt within 2 months before the study.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine – Shanghai Jiao Tong University School of Medicine
  • Overall Official(s)
    • Hong Lu, M.D., Principal Investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Overall Contact(s)
    • Yingjie Ji, M.D., 86+15800575527, jiyingjie39@outlook.com

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