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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024660
Receipt No. R000027373
Scientific Title the relationship between VATS and postoperative quality of life
Date of disclosure of the study information 2016/10/31
Last modified on 2019/11/03

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Basic information
Public title the relationship between VATS and postoperative quality of life
Acronym VATS and postoperative quality of life
Scientific Title the relationship between VATS and postoperative quality of life
Scientific Title:Acronym VATS and postoperative quality of life
Region
Japan

Condition
Condition the patients undergoing VATS lobectomy
Classification by specialty
Surgery in general Anesthesiology Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to identify chronic pain and life function
Basic objectives2 Others
Basic objectives -Others the relationship of daily life
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOR 40 chronic pain
Key secondary outcomes SF8 TMIG Index WHODAS sleep index

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Questionnaire
Actigraph
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 elective VATS lobectomy under general anesthesia
Seven or more days of hospitalization is expected
Key exclusion criteria post VATS surgery patients
use of sedatives
Patient with mental illness or neuropathy
Patient preoperative evaluation is difficult
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 09079627114
Email nwnh0131@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nara Medical University
Address Kashihara shijo 840
Tel 09079627114
Email nwnh0131@yahoo.co.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
2016 Year 10 Month 31 Day

Related information
URL releasing protocol www
Publication of results Unpublished

Result
URL related to results and publications www
Number of participants that the trial has enrolled 24
Results
Refer to publication
Results date posted
2019 Year 11 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to publicatipn
Participant flow
Refer to publicatipn
Adverse events
Refer to publicatipn
Outcome measures
Refer to publicatipn
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 11 Day
Date of IRB
2016 Year 08 Month 18 Day
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2018 Year 09 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027373

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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