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Recruiting Not applicable

Postoperative Effects of Different Enterostomy Approaches

NCT05853094 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-06-23
Last updated
2023-05-19

Condition(s) studied

Colorectal CancerColorectal Neoplasms MalignantIntestinal Neoplasms, Malignant

Investigational drug(s) / intervention(s)

IleostomyTransverse colostomy

Ileostomy: Protective loop ileostomy after low anterior resection

Transverse colostomy: Protective loop transverse colostomy after low anterior resection

Study summary

Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low rectal cancer after radical surgery from the perspective of intestinal microecology.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing — 1 month
    Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
  • Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing — 6 months
    Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
  • Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing — 3 years
    Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05853094 on ClinicalTrials.gov ↗ ← All trials in China