UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043542 |
|---|---|
| Receipt number | R000049211 |
| Scientific Title | Effect of skeletal muscle mass on postoperative loss of independence |
| Date of disclosure of the study information | 2021/03/29 |
| Last modified on | 2022/09/07 12:28:20 |
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Basic information
Public title
Effect of skeletal muscle mass on postoperative loss of independence
Acronym
Perioperative maintenance of activities of daily living
Scientific Title
Effect of skeletal muscle mass on postoperative loss of independence
Scientific Title:Acronym
Perioperative maintenance of activities of daily living
Region
| Japan |
Condition
Condition
Patients undergoing surgical procedures
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of preoperative skeletal muscle mass on postoperative loss of independence. In this study, we focused on skeletal muscle mass, which can be measured easily and noninvasively, as a candidate predictor of postoperative loss of independence.
Basic objectives2
Others
Basic objectives -Others
Observational studies to examine the relationship between exposures and outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative decline in activities of daily living (ADL): defined as a decrease in ADL score of at least 1 point from the preoperative level, calculated based on the algorithm developed in previous studies.
Key secondary outcomes
intensive care unit length of stay, length of hospital stay, incidence of postoperative complications, postoperative survival rate
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for the following surgeries: carotid endarterectomy, peripheral vascular bypass, total hip replacement, total knee replacement, colorectal resection, hepatectomy, pancreaticoduodenectomy, total pneumonectomy, lung lobectomy, gastrectomy, nephrectomy, and cystectomy.
Key exclusion criteria
Patients undergoing emergency surgery (surgery performed within 24 hours of the decision to operate), patients who refused to participate in this study, and patients who cannot fully understand Japanese.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Mizota |
Organization
Kyoto University Hospital
Division name
Department of Anesthesia
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3213
mizota@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Mizota |
Organization
Kyoto University Hospital
Division name
Department of Anesthesia
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3213
Homepage URL
mizota@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Anesthesia, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-753-4642
ethcom@kuhp.kyoto-u.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
| 2021 | Year | 03 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was approved by the Ethics Committee on March 5, 2021 (Approval number: R2836).
Management information
Registered date
| 2021 | Year | 03 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049211
