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

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 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

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

Value
https://center6.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