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

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 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

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

Value
https://center6.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