UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053485 |
|---|---|
| Receipt number | R000061045 |
| Scientific Title | Evaluation of Skeletal Muscle Mass from Blood Test Data in Emergency Gastrointestinal Surgery Cases |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/30 18:49:18 |
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Basic information
Public title
Evaluation of Skeletal Muscle Mass from Blood Test Data in Emergency Gastrointestinal Surgery Cases
Acronym
Evaluation of Skeletal Muscle Mass from Blood Test Data in Emergency Gastrointestinal Surgery Cases
Scientific Title
Evaluation of Skeletal Muscle Mass from Blood Test Data in Emergency Gastrointestinal Surgery Cases
Scientific Title:Acronym
Evaluation of Skeletal Muscle Mass from Blood Test Data in Emergency Gastrointestinal Surgery Cases
Region
| Japan |
Condition
Condition
Requiring emergency surgery Gastrointestinal diseases
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Calculating the Skeletal Muscle Index Using Preoperative Blood Samples from Patients Undergoing Emergency Gastrointestinal Surgery and Investigating its Correlation with Skeletal Muscle Mass Measured by Conventional Methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal Muscle Index
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient must be 20 years of age or older.
Patients undergoing emergency gastrointestinal surgery.
Patients or their surrogates have consented to participate in the study.
Key exclusion criteria
Patients deemed unsuitable for the study by the responsible physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Reiji |
| Middle name | |
| Last name | Nozaki |
Organization
Mito Saiseikai General Hospital
Division name
Department of Surgery
Zip code
311-4998
Address
3-3-10 Futabadai, Mito City, Ibaraki
TEL
029-254-5151
reiji.nozaki@mito-saisei.jp
Public contact
Name of contact person
| 1st name | Reiji |
| Middle name | |
| Last name | Nozaki |
Organization
Mito Saiseikai General Hospital
Division name
Department of Surgery
Zip code
311-4151
Address
3-3-10 Futabadai, Mito City, Ibaraki
TEL
029-254-5151
Homepage URL
reiji.nozaki@mito-saisei.jp
Sponsor or person
Institute
Mito Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committeeof Mito Saiseikai General Hospital
Address
3-3-10 Futabadai, Mito City, Ibaraki
Tel
029-254-5151
reiji.nozaki@mito-saisei.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 | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061045
