CClinicalTrials.gg
Status unknownNCT05066048IMDCBAITROCCUpdated May 9, 2022

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

An observational study in Colorectal Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasms
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 300 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with an appendectomy and meet the above conditions

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • The appendectomy group
  • Colorectal cancer group
  • Normal group
06

What researchers measure

Primary outcomes

  1. Species composition of fecal microbial

    The types of microorganisms of fecal microbial

    Time frame: 1 year

Secondary outcomes

  1. weight in kilograms

    weight of enrolled patients

    Time frame: baseline, pre-procedure

  2. height in meters

    height of enrolled patients

    Time frame: baseline, pre-procedure

  3. age in year

    age of enrolled patients

    Time frame: baseline, pre-procedure

07

Study locations

1 site
  • The First Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, Shaanxi 710061, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05066048
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Oct 4, 2021
Start date
Apr 30, 2021
Primary completion
Mar 31, 2022
Completion
Jan 31, 2024 (estimated)
Last update
May 9, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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