UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041604 |
|---|---|
| Receipt number | R000047493 |
| Scientific Title | Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study |
| Date of disclosure of the study information | 2020/08/29 |
| Last modified on | 2023/03/13 08:21:01 |
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Basic information
Public title
Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study
Acronym
Evaluation of muscle mass changes during perioperative management
Scientific Title
Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study
Scientific Title:Acronym
Evaluation of muscle mass changes during perioperative management
Region
| Japan |
Condition
Condition
Patients who were received surgical operation including general surgery, neurosurgery, urologic surgery, otorhinolaryngolical surgery, and oral surgery.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Oto-rhino-laryngology |
| Urology | Neurosurgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure muscle mass changes during perioperative management using body composition analyzer, InBody. We measure the body composition of patients at both pre- and post operation, using InBody, which is non-invasive body composition analyzer with bioelectrical impedance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure changes of muscle mass and water balance during perioperative management
Key secondary outcomes
Biochemical data, change of muscle mass by part of body. Relation between operation time, bleeding and change of muscle mass.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing elective general surgery, neurosurgery, urologic surgery, otorhinolaryngolical surgery, and oral surgery.
2) Patients aged over 18.
3) Patients measuring body composition with InBody.
Key exclusion criteria
1) Patients who require emergency surgery.
2) Patients who were judged to be inappropriate as subjects by the study investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | Yoshihito |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Anesthesiology and General ICU
Zip code
480-1195
Address
1-1 Karimata Yazako Nagakute city Aichi prefecture
TEL
0561-62-3311
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | IRB |
| Middle name | |
| Last name | Aichi Medical University |
Organization
Aichi Medical University
Division name
Anesthesiology and general ICU
Zip code
4660812
Address
1-1 Karimata Yazako Nagakute city Aichi prefectute
TEL
0561623311
Homepage URL
aichi-med@esct.bvits.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Aichi
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University IRB
Address
1-1 Karimata Yazako Nagakute city Aichi prefecture
Tel
0561623311
aichi-med@esct.bvits.com
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
| 2020 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047493
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047493
Number of participants that the trial has enrolled
100
Results
Objects are
Results date posted
| 2022 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The results are
Participant flow
Methods are
Adverse events
Non
Outcome measures
Main results are
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
single center, prospective cohort observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047493
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| Registered date | File name |
| Research case data | |
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