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Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown
Phase 1

Conditions

Laparoscopic Cholecystectomy

Treatments

Procedure: Laparoscopic cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03836170
rjkls20190208

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Laparoscopic cholecystectomy
Experimental group
Description:
A laparoscopic cholecystectomy was performed to remove the gallbladder
Treatment:
Procedure: Laparoscopic cholecystectomy

Trial contacts and locations

1

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Central trial contact

Yingjie Ji, M.D.

Data sourced from clinicaltrials.gov

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