Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer

• Conditions: Colorectal Neoplasms

• Registration Number: NCT05066048
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study Start: 2021-04-30
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Status Verified: 2022-03
• Primary Completion: 2022-03-31
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients undergoing appendectomy due to appendicitis;
• 6-36 months after appendectomy;
• Patients with no obvious abnormality observed by colonoscopy;
• Age between 20 and 85.

Exclusion Criteria

• A. Any history of malignancy or disease
• Any inflammatory bowel disease (IBD) prior to study inclusion;
• Antibiotics and hormone drugs taken within the last three months;
• Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
• Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Species composition of fecal microbial	1 year	The types of microorganisms of fecal microbial

Secondary Outcome Measures

Name	Time	Method
age in year	baseline, pre-procedure	age of enrolled patients
weight in kilograms	baseline, pre-procedure	weight of enrolled patients
height in meters	baseline, pre-procedure	height of enrolled patients

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China