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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043695
Receipt No. 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

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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
Email 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
Email ishiura-prs@med.mie-u.ac.jp

Sponsor
Institute department of plastic and reconstructive surgery, university of Mie
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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