Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05853094
Eligibility Criteria:
Inclusion Criteria:
1. Pathological confirmed adenocarcinoma of the rectum;
2. Patients age between 18-80;
3. Baseline AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version);
4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
5. Patients voluntarily sign informed consent.
Exclusion Criteria:
1. Other types of rectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma);
2. Combination of rectal cancer with multiple carcinomas;
3. Pre-operative presence of acute and chronic infectious diseases or foci of infection;
4. Intraoperative radical surgery was not performed for various reasons；
5. Colostomy was not performed at the same time as the radical rectal cancer surgery;
6. Combined with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
7. Metastatic cancer;
8. Serious heart, lung, liver and kidney disease, can not tolerate surgery;
9. Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values;
10. Renal impairment with Cr ≥ 2 times the upper limit of normal or BUN ≥ 2 times the upper limit of normal;
11. Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases;
12. Pregnancy;
13. Mental illness or serious intellectual disability who cannot describe their feelings correctly;
14. Severe coagulation disorder, bleeding tendency;
15. Patients with severe uncontrolled medical disease, recent history of myocardial infarction (within 3 months), uncontrolled severe hypertension and severe diabetes mellitus;
16. Patients need to be on antibiotics/other probiotics for a long time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05853094
Study Brief:
Protocol Section:
NCT05853094