UMIN-CTR Clinical Trial

Basic information
Public title	The effect of preoperative skeletal muscle mass on perioperative complication
Acronym	The effect of preoperative skeletal muscle mass on perioperative complication
Scientific Title	The effect of preoperative skeletal muscle mass on perioperative complication
Scientific Title:Acronym	The effect of preoperative skeletal muscle mass on perioperative complication
Region	Japan

Condition
Condition	postoperative delirium
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate whether preoperative skeletal muscle mass affects perioperative complications including postoperative delirium
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative delirium
Key secondary outcomes	the lowest intraoperative systemic blood pressure, postoperative complications, length of hospitalization, length of stay in intensive care unit and postoperative consciousness

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent digestive, esophageal or orthopedic surgery
Key exclusion criteria	Patients who revoked the consent, lost the anesthesia record or had no computed tomography
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Goyagi
Organization	Akita University Graduate School of Medicine
Division name	Anesthesia and Intensive Care Medicine
Zip code	010-0843
Address	1-1-1, Hondo, Akita-city, Akita
TEL	018-884-6175
Email	tgoyagi@doc.med.akita-u.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Goyagi
Organization	Akita University Graduate School of Medicine
Division name	Anesthesia and Intensive Care Medicine
Zip code	010-8543
Address	1-1-1, Hondo, Akita-city, Akita
TEL	018-884-6175
Homepage URL
Email	tgoyagi@doc.med.akita-u.ac.jp

Sponsor
Institute	Akita University
Institute
Department

Funding Source
Organization	Akita University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB
Address	1-1-1, Hondo, Akita-city, Akita
Tel	018-884-6216
Email	soken@hos.akita-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 10 Month 18 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	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 01 Day
Date of IRB	2021 Year 09 Month 10 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2024 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will extract the perioperative data from the medical record.

Management information
Registered date	2021 Year 10 Month 18 Day
Last modified on	2021 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052078