UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049211