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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05066048

Acronym

IMDCBAITROCC

Enrollment

300

Registered

2021-10-04

Start date

2021-04-30

Completion date

2024-01-31

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Species composition of fecal microbial	1 year	The types of microorganisms of fecal microbial

Secondary

Measure	Time frame	Description
weight in kilograms	baseline, pre-procedure	weight of enrolled patients
height in meters	baseline, pre-procedure	height of enrolled patients
age in year	baseline, pre-procedure	age of enrolled patients

Countries

China

Outcome results