UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045785 |
|---|---|
| Receipt number | R000052078 |
| Scientific Title | The effect of preoperative skeletal muscle mass on perioperative complication |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2021/10/18 11:21:07 |
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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
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
tgoyagi@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052078
