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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030389
Receipt No. R000034696
Scientific Title Relationship between perioperative activity level and complication after surgery
Date of disclosure of the study information 2018/01/01
Last modified on 2019/06/17

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Basic information
Public title Relationship between perioperative activity level and complication after surgery
Acronym Relationship between perioperative activity level and complication after surgery
Scientific Title Relationship between perioperative activity level and complication after surgery
Scientific Title:Acronym Relationship between perioperative activity level and complication after surgery
Region
Japan

Condition
Condition Surgical case
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By using an activity meter, we examine the correlation between peri-operative activity level and postoperative complications. We also examine the relationship between sleep time and delirium after surgery using an activity meter.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of relationship between complications after surgery and activity level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Activity meter
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 (1) Surgical treatment under general anesthesia
(2) Patient's age is 20 years or older
(3) Patients who obtained written consent
Key exclusion criteria (1) Emergency surgery
(2) Patients who require management in the intensive care unit for a long period after surgery
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name Hiroya
Middle name
Last name Iida
Organization Shiga University of Medical Science
Division name Department of surgery
Zip code 520-2192
Address Seta-tsukinowa cho, Otsu, Shiga
TEL 077-548-2238
Email hiroya@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Hiroya
Middle name
Last name Iida
Organization Shiga University of Medical Science
Division name Department of surgery
Zip code 520-2192
Address Seta-tsukinowa cho, Otsu, Shiga
TEL 077-548-2238
Homepage URL
Email hiroya@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization N/A
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 Shiga University of Medical Science
Address Seta tsukinowa-cho, Otsu, Shiga, Japan
Tel 077-548-2238
Email hiroya@belle.shiga-med.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
2018 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 13 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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