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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027370
Receipt No. R000031363
Scientific Title Effect of early postoperative diet
Date of disclosure of the study information 2017/05/22
Last modified on 2018/06/08

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Basic information
Public title Effect of early postoperative diet
Acronym Effect of early postoperative diet
Scientific Title Effect of early postoperative diet
Scientific Title:Acronym Effect of early postoperative diet
Region
Japan

Condition
Condition The patient who undergo orthopedic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the effect of early diet after orthopedic surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Satisfaction and opinion about the postoperative diet
Key secondary outcomes Time to hope for postoperative eating and drinking
Intake of postoperative diet
Postoperative nausea and vomiting
Abdominal symptoms such as abdominal distension
Severity of pain
Quality of sleep

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Early diet after orthopedic surgery
Interventions/Control_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
5 years-old <
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria The patient who undergo elective orthopedic surgery by general anesthesia
Key exclusion criteria Over 65 years old
Preoperative diet is not normal diet
Delayed emergence
Dementia
History of central nervous disease
Spinal surgery
Severe missing teeth
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko Shirasawa
Organization Yamaguchi Rosai Hospital
Division name Department of Anesthesia
Zip code
Address 1315-4 Onoda, Sanyoonoda, Yamaguchi, Japan
TEL 0836-83-2881
Email y-shirasawa@yamaguchih.johas.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Shirasawa
Organization Yamaguchi Rosai Hospital
Division name Department of Anesthesia
Zip code
Address 1315-4 Onoda, Sanyoonoda, Yamaguchi, Japan
TEL 0836-83-2881
Homepage URL
Email y-shirasawa@yamaguchih.johas.go.jp

Sponsor
Institute Yamaguchi Rosai Hospital
Institute
Department

Funding Source
Organization Yamaguchi Rosai Hospital
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
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Completed
Date of protocol fixation
2017 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 22 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 17 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031363

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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