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临床试验/NCT03836170
NCT03836170Unknown1 期

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

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年5月15日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
40
试验地点
1
主要终点
Change of gut microbiota after laparoscopic cholecystectomy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;
  • 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.

排除标准

  • 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.

研究组 & 干预措施

Laparoscopic cholecystectomy

Experimental

A laparoscopic cholecystectomy was performed to remove the gallbladder

干预措施: Laparoscopic cholecystectomy (Procedure)

结局指标

主要结局

Change of gut microbiota after laparoscopic cholecystectomy

时间窗: Three months and one year after completion of LC

Three months and one year after completion of laparoscopic cholecystectomy therapy, gut microbiota was assessed by 16S rDNA high-throughput sequencing.

次要结局

未报告次要终点

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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