UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000049861