Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

NCT03836170 | Unknown Phase 1 DMC

• 1 other identifier: rjkls20190208
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy

Keywords

laparoscopic cholecystectomy; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Laparoscopic cholecystectomy

EXPERIMENTAL

A laparoscopic cholecystectomy was performed to remove the gallbladder

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy 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.

Laparoscopic cholecystectomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gallbladder polyps diameter mm \>10;
• The history of the symptoms of patients with gallbladder stones, there was no history of acute attack in the past month;
• Age \<70 years old;
• No serious systemic diseases such as diabetes, hypertension, heart disease, lung disease and so on/American anesthesia Association (ASA) grade I or II;
• BMI\<30;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Hong Lu, M.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingjie Ji, M.D.

CONTACT

86+15800575527; jiyingjie39@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 11, 2019
• Study Start: May 15, 2018
• Primary Completion: May 20, 2019
• Study Completion: June 1, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)