Comparing ileostomy and transverse colostomy after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the postoperative effects of protective ileostomy versus transverse colostomy in patients with low rectal cancer following radical surgery. It aims to assess the occurrence of complications, serious side effects from adjuvant chemotherapy, and disease recurrence, focusing on intestinal microecology. The research addresses the common complication of anastomotic leakage, which can significantly impact recovery and outcomes. By comparing these two surgical approaches, the study seeks to determine which method better prevents complications and supports healing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yanlei Ma, PhD — Fudan University
• Study coordinator: Yanlei Ma, PhD
• Email: yanleima@fudan.edu.cn
• Phone: (86)13122680635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.