UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027370 |
|---|---|
| Receipt number | R000031363 |
| Scientific Title | Effect of early postoperative diet |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2018/06/08 10:40:09 |
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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
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
y-shirasawa@yamaguchih.johas.go.jp
Sponsor or person
Institute
Yamaguchi Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031363
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
