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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043542
Receipt No. 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 2021/04/17

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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
Email 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
Email mizota@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Anesthesia, Kyoto University Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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