UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029876 |
|---|---|
| Receipt number | R000034118 |
| Scientific Title | Development of Safe Peri-operative Management for Surgical Patients using Body Composition Analyser |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2019/05/13 10:30:57 |
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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
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
yama-t@med.kawasaki-m.ac.jp
Public contact
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
yama-t@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Department of General Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
