UMIN-CTR Clinical Trial

Basic information
Public title	Development of Safe Peri-operative Management for Surgical Patients using Body Composition Analyser
Acronym	InBody and Preoperative Management
Scientific Title	Development of Safe Peri-operative Management for Surgical Patients using Body Composition Analyser
Scientific Title:Acronym	InBody and Preoperative Management
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Operative medicine Blood transfusion Intensive care medicine Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Surgical interventions and chemotherapy affect the body composition of patients, depending on the target organs, surgical techniques, stage of the disease and fluid/nutrition management. The change in the body composition is one of the important factors to influence the post operative recovery and complication rate. In this study, we plan to measure the body composition of patients in both inpatient and outpatient settings in Kawasaki Medical School General Medical Centre, using InBody 770&S1, which are highly sophisticated non-invasive body composition analysers involving bioelectrical impedance. Our aim is to investigate if the body composition analysis would become a safe and efficient assessment tool for peri-operative management of surgical patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Post operative complications based on Clavien-Dindo classification
Key secondary outcomes	Other adverse event based on CTCAEv4.0, duration of stay in ICU, other clinical information from medical records

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	20 years-old >=
Gender	Male and Female
Key inclusion criteria	All surgical patients who undergo operations and/or are receiving chemotherapy at Kawasaki Medical School General Medical Centre
Key exclusion criteria	Anyone not include above
Target sample size	300

Research contact person
Last name of lead principal investigator	1st name Tomoki Middle name Last name Yamatuji
Organization	Kawasaki Medical School
Division name	Department of General Surgery
Zip code	700-8505
Address	2-6-1, Nakasange, Kita-Ward, Okayama-City, Okayama-Prefecture
TEL	0862252111
Email	yama-t@med.kawasaki-m.ac.jp

Public contact
1st name of contact person	1st name Tomoki Middle name Last name Yamatuji
Organization	Kawasaki Medical School
Division name	Department of General Surgery
Zip code	700-8505
Address	2-6-1, Nakasange, Kita-Ward, Okayama-City, Okayama-Prefecture
TEL	0862252111
Homepage URL
Email	yama-t@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School Department of General Surgery
Institute
Department

Funding Source
Organization	None
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	Kawasaki Medical School Hospital Ethics Committee
Address	577 Matsushima Kurashiki City Okayama Prefecture
Tel	086-464-1076
Email	kmsrec@med.kawasaki-m.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	2017 Year 11 Month 09 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	2017 Year 08 Month 02 Day
Date of IRB	2017 Year 08 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 02 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non applicable

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034118