UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043695 |
|---|---|
| Receipt number | R000049861 |
| Scientific Title | Prospective randomized crossover study of the effect of caffeine consumption on the efficiency of surgical closures |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2021/09/21 21:30:21 |
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Basic information
Public title
study of of the effect of caffeine consumption on the efficiency of surgical closures
Acronym
coffee
Scientific Title
Prospective randomized crossover study of the effect of caffeine consumption on the efficiency of surgical closures
Scientific Title:Acronym
coffee
Region
| Japan |
Condition
Condition
surgeon
Classification by specialty
| Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of typical self-administered doses of caffeine on surgical closure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to complete the repair, quality of the repair and surgical skills one hour later intaking caffeine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
coffee including 200 mg caffeine consumption before surgical closure (day 1)
decaffeinated coffee consumption before surgical closure (day 2)
Interventions/Control_2
decaffeinated coffee consumption before surgical closure (day 1)
coffee including 200 mg caffeine consumption before surgical closure (day 2)
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
medical student
Key exclusion criteria
1) Those who have already received special training in suturing.
2) Those who addicted to caffeine or have a caffeine allergy
3) pregnant woman or woman during lactation
4) Those who judged by the principal investigator or sub-investigator to be inappropriate for participation in the research.
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Isiura |
Organization
University of Mie
Division name
plastic and reconstructive surgery
Zip code
5148507
Address
Edobashi 2 chome 174, Tsu, Mie, Japan
TEL
0592321111
ishiura-prs@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Ishiura |
Organization
University of Mie
Division name
plastic and reconstructive surgery
Zip code
5148507
Address
Edobashi 2 chome 174, Tsu, Mie, Japan
TEL
0592321111
Homepage URL
ishiura-prs@med.mie-u.ac.jp
Sponsor or person
Institute
department of plastic and reconstructive surgery, university of Mie
Institute
Department
Personal name
Funding Source
Organization
department of plastic and reconstructive surgery, university of Mie
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
-
Address
Edobashi 2 chome 174, Tsu, Mie, Japan
Tel
0592315045
kk-sien@mo.medic.mie-u.ac.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
三重大学病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049861
