Actively Recruiting
Postoperative Effects of Different Enterostomy Approaches
Led by Fudan University · Updated on 2023-05-19
300
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postoperative Effects of Different Enterostomy Approaches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed adenocarcinoma of the rectum
- Age between 18 and 80 years
- AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version)
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Voluntary signed informed consent
You will not qualify if you...
- Other rectal cancer types such as adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma
- Presence of multiple carcinomas along with rectal cancer
- Acute or chronic infectious diseases or infection foci before surgery
- Radical surgery not performed during operation
- No colostomy performed at the time of radical rectal cancer surgery
- Conditions requiring emergency surgery like intestinal obstruction, perforation, bleeding, or peritonitis
- Metastatic cancer
- Severe heart, lung, liver, or kidney disease preventing surgery
- Active liver disease or abnormal liver function with ALT, AST, or TBIL over twice the normal limit
- Renal impairment with creatinine or BUN over twice the normal limit
- Blood leukocytes or platelets below normal limits or other blood diseases
- Pregnancy
- Mental illness or serious intellectual disability preventing accurate communication
- Severe coagulation disorders or bleeding tendencies
- Severe uncontrolled medical diseases, recent myocardial infarction (within 3 months), uncontrolled severe hypertension, or severe diabetes
- Long-term use of antibiotics or other probiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Y
Yanlei Ma, PhD
CONTACT
Y
Yichi Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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