UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054795 |
|---|---|
| Receipt number | R000062595 |
| Scientific Title | Rehabilitation nutrition in an acute care gastroenterology and surgery unit |
| Date of disclosure of the study information | 2024/06/28 |
| Last modified on | 2024/06/27 12:02:39 |
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Basic information
Public title
Rehabilitation nutrition in an acute care gastroenterology and surgery unit
Acronym
Rehabilitation nutrition in an acute care gastroenterology and surgery unit
Scientific Title
Rehabilitation nutrition in an acute care gastroenterology and surgery unit
Scientific Title:Acronym
Rehabilitation nutrition in an acute care gastroenterology and surgery unit
Region
| Japan |
Condition
Condition
Gastrointestinal Surgical Diseases
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the effectiveness of interventions conducted at our hospital under the concept of rehabilitation nutrition, which combines rehabilitation and nutritional therapy, in a gastrointestinal surgery ward with a high risk of low nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMI at admission, start of intervention, and discharge
Key secondary outcomes
MNA-SF (Mini Nutritional Assessment Short-Form) and BI (Barthel Index) at admission, start of intervention, and discharge
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
BMI less than 18.5, MNA-SF less than or equal to 7 points, and rehabilitation with intensity greater than or equal to walking
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Towata |
Organization
Tokai University Hospital
Division name
Department of Rehabilitation Technology
Zip code
259-1193
Address
143, Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
t-towata@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Towata |
Organization
Tokai University Hospital
Division name
Department of Rehabilitation Technology
Zip code
259-1193
Address
143, Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
Homepage URL
t-towata@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Takahi Towata
Funding Source
Organization
Tokai University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University Hospital
Address
143, Shimokasuya, Isehara-shi, Kanagawa
Tel
0463931121
tokai-rec@tokai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 28 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Patients admitted to the Gastroenterological Surgery Unit of the hospital between August 1, 2022 and September 30, 2023, who met the inclusion criteria and were eligible for inclusion.
Management information
Registered date
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062595
