Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

Analysis by High-throughput Sequencing: the Impact of Cholecystectomy on Gut Microbiome in Adults

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Sub-Investigator: Hui Wang, M.D.
      • Principal Investigator: Hong Lu, M.D.,Ph.D.
      • Sub-Investigator: Yingjie Ji, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Laparoscopic cholecystectomy; A laparoscopic cholecystectomy was performed to remove the gallbladder

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2018
• Primary Completion (ANTICIPATED): May 20, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (ACTUAL): February 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: gut microbiota; laparoscopic cholecystectomy
• Other Study ID Numbers: rjkls20190208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No