Comparing ileostomy and transverse colostomy after rectal cancer surgery
A Single-centre, Randomized Study to Compare the Outcomes of Protected Transverse Colostomy Versus Ileostomy After Low Anterior Resection of Low Rectal Cancer From the Perspective of Intestinal Microecology
This study is testing whether a protective ileostomy or a transverse colostomy after rectal cancer surgery helps patients recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05853094 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with pathologically confirmed adenocarcinoma of the rectum at AJCC stages I-III.
Not a fit: Patients with other types of rectal cancer or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing treatment for low rectal cancer.
How similar studies have performed: While there have been studies on stoma-related complications, this specific comparison of ileostomy and transverse colostomy in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.