Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03836170
• Other study ID #: rjkls20190208
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yingjie Ji, M.D.
• Phone: 86+15800575527
• Email: jiyingjie39[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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