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โ† Trials
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Postoperative Effects of Different Enterostomy Approaches

RecruitingNAAges 18 Years - 80 YearsAllFudan University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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๏ผ› 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 โ‰ฅ 2 times the upper limit of normal or BUN โ‰ฅ 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.
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What it tests

  • Ileostomy
  • Transverse colostomy
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Where

1 site
Fudan University Shanghai Cancer Center
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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