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

NCT ID: NCT05066048

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2024-01-31

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.

Conditions

Colorectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The appendectomy group

No interventions assigned to this group

Colorectal cancer group

No interventions assigned to this group

Normal group

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XJTU1AF-CRF-2020-004

Identifier Type: -

Identifier Source: org_study_id