UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041604
Receipt No. R000047493
Scientific Title Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study
Date of disclosure of the study information 2020/08/29
Last modified on 2020/08/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study
Acronym Evaluation of muscle mass changes during perioperative management
Scientific Title Evaluation of muscle mass changes during perioperative management using body composition analyzer, InBody: single center, prospective cohort observational study
Scientific Title:Acronym Evaluation of muscle mass changes during perioperative management
Region
Japan

Condition
Condition Patients who were received surgical operation including general surgery, neurosurgery, urologic surgery, otorhinolaryngolical surgery, and oral surgery.
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Oto-rhino-laryngology
Urology Neurosurgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To measure muscle mass changes during perioperative management using body composition analyzer, InBody. We measure the body composition of patients at both pre- and post operation, using InBody, which is non-invasive body composition analyzer with bioelectrical impedance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To measure changes of muscle mass and water balance during perioperative management
Key secondary outcomes Biochemical data, change of muscle mass by part of body. Relation between operation time, bleeding and change of muscle mass.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients undergoing elective general surgery, neurosurgery, urologic surgery, otorhinolaryngolical surgery, and oral surgery.
2) Patients aged over 18.
3) Patients measuring body composition with InBody.
Key exclusion criteria 1) Patients who require emergency surgery.
2) Patients who were judged to be inappropriate as subjects by the study investigators.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshihito
Middle name Yoshihito
Last name Fujita
Organization Aichi Medical University
Division name Anesthesiology and General ICU
Zip code 480-1195
Address 1-1 Karimata Yazako Nagakute city Aichi prefecture
TEL 0561-62-3311
Email fujita.yoshihito.823@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Yoshihito
Middle name
Last name Fujita
Organization Aichi Medical University
Division name Anesthesiology and general ICU
Zip code 4660812
Address 1-1 Karimata Yazako Nagakute city Aichi prefectute
TEL 0561623311
Homepage URL
Email fujita.yoshihito.823@mail.aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Aichi

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

IRB Contact (For public release)
Organization Aichi Medical University IRB
Address 1-1 Karimata Yazako Nagakute city Aichi prefecture
Tel 0561623311
Email aichi-med@esct.bvits.com

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
2020 Year 08 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
2020 Year 05 Month 21 Day
Date of IRB
2020 Year 05 Month 21 Day
Anticipated trial start date
2020 Year 08 Month 29 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information single center, prospective cohort observational study

Management information
Registered date
2020 Year 08 Month 29 Day
Last modified on
2020 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.