Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2019-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Laparoscopic cholecystectomy

A laparoscopic cholecystectomy was performed to remove the gallbladder

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes