The efficacy and safety of green tea consumption after colon surgery: A randomized controlled trial
- Conditions
- Colon cancer
- Registration Number
- JPRN-UMIN000048174
- Lead Sponsor
- Tochigi Medical Center Shimotsuga
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Participants who are unable to provide informed consent or comply with research protocols 2. Participants who are known to have problems with mental health or language ability 3. Participants who are participating in other interventional trials 4. Emergency surgery 5. Multiple organ resection at the time of surgery 6. Extension or closure of an enterostomy at the time of surgery 7. Participants undergoing colostomy or ileostomy 8. Complete obstruction 9. Hypersensitivity or allergy to caffeine or green tea 10. American Society of Anesthesiologists (ASA) IV or V physical status score 11. Alcoholism or drug abuse 12. Regular intake of more than 800 mg of caffeine (8-10 cups of coffee) per day 13. Previous extensive abdominal surgery (excluding appendicectomy, cholecystectomy, hernia repair, or cesarean section) 14. Grade III or higher heart failure (NYHA) 15. Opioid analgesics or steroids greater than 5 mg/day for at least 7 days prior to surgery 16. Long-term use of glucocorticoids or stimulant laxatives 17. Taking antidepressants 18. Severe obesity (BMI > 32) and severe malnutrition (BMI < 15) 19. Hypertensive emergencies (>180/120 mmHg) 20. Pregnancy, lactation, or possible childbirth 21. Liver failure and/or cirrhosis (MELD > 15) 22. Drugs that are substrates or inhibitors of CYP1A2 enzymes (e.g., new quinolone antibacterial agents)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method