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

NCT05066048 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Species composition of fecal microbial

  The types of microorganisms of fecal microbial

  1 year

Secondary Outcomes (3)

• weight in kilograms

  baseline, pre-procedure

• height in meters

  baseline, pre-procedure

• age in year

  baseline, pre-procedure

Study Arms (3)

The appendectomy group

Colorectal cancer group

Normal group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an appendectomy and meet the above conditions

You may qualify if:

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

You may not qualify if:

• A. Any history of malignancy or disease
• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: October 4, 2021
• Study Start: April 30, 2021
• Primary Completion: March 31, 2022
• Study Completion: January 31, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-03

Locations

CN (1)