UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048174 |
|---|---|
| Receipt number | R000054898 |
| Scientific Title | The efficacy and safety of green tea consumption after colon surgery: A randomized controlled trial |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2024/12/28 19:54:56 |
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Basic information
Public title
The efficacy and safety of green tea consumption after colon surgery: A randomized controlled trial
Acronym
The efficacy and safety of green tea consumption after colon surgery: A randomized controlled trial
Scientific Title
The efficacy and safety of green tea consumption after colon surgery: A randomized controlled trial
Scientific Title:Acronym
Postoperative green tea trial
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of green tea on postoperative short outcomes after colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to first defecation (hours)
Definition: time from the end of surgery to first defecation (hours)
Period: from surgery to the first defecation
Key secondary outcomes
1. Length of hospital stay (days)
Definition: Days from operation to discharge
Period: from operation to discharge
2. Postoperative ileus
Definition: the number of patients who had postoperative ileus described as a narrow-mindedness to oral nourishment without clinical or radiological indications of obstruction, that either 1) requires nasogastric tube insertion; or b) was related with two of the accompanying: nausea/vomiting, stomach distension, and the nonattendance of flatus hours on or after postoperative day two, divided by total patients in each group
Period: within postoperative 30 days
3. Postoperative complications
Definition: the number of patients with postoperative complications based on Clavien-Dindo classification of more than 2.
Period: within postoperative 30 days.
4. the amount of drinking (ml)
Definition: the mean amount of drinking per day (ml)
Period: from surgery to the first defecation
5. All adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Postoperative green tea 600ml per day
Period: from postoperative 1 day to the time to first defication
Interventions/Control_2
Postoperative water 600ml per day
Period: from postoperative 1 day to the time to first defication
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults (male and female) aged more than 18 years olds
2. Participants with colon cancer
Key exclusion criteria
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)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Tochigi Medical Center Shimotsuga
Division name
Surgery
Zip code
329-4498
Address
420-1 Kawatsure, Ouhiramachi, Tochigi-City, Tochigi, Japan
TEL
0282-22-2551
m06105jw@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Tochigi Medical Center Shimotsuga
Division name
Surgery
Zip code
329-4498
Address
420-1 Kawatsure, Ouhiramachi, Tochigi-City, Tochigi, Japan
TEL
0282-22-2551
Homepage URL
m06105jw@jichi.ac.jp
Sponsor or person
Institute
Tochigi Medical Center Shimotsuga
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Tochigi Medical Center Shimotsuga
Address
420-1 Kawatsure, Ouhiramachi, Tochigi-City, Tochigi, Japan
Tel
0282-22-2551
rinri@tochigi-medicalcenter.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
とちぎメディカルセンターしもつが（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://doi.org/10.7759/cureus.72157
Management information
Registered date
| 2022 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054898
