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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017597
Receipt No. R000020399
Scientific Title Single-institutional Prospective QOL assessment in patients underwent thoracic surgery
Date of disclosure of the study information 2015/05/18
Last modified on 2019/05/19

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Basic information
Public title Single-institutional Prospective QOL assessment in patients underwent thoracic surgery
Acronym Prospective QOL assessment in patients underwent thoracic surgery
Scientific Title Single-institutional Prospective QOL assessment in patients underwent thoracic surgery
Scientific Title:Acronym Prospective QOL assessment in patients underwent thoracic surgery
Region
Japan

Condition
Condition any disease requiring thoracic surgery
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess patient-reported, health-related QOL in patients underwent thoracic surgery during perioperative, mid-term, long-term period.
Basic objectives2 Others
Basic objectives -Others To clarify the factors affecting the QOL in each disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes raw scores, utility value and VAS value of each QOL questionnaire (EQ5D-5L)
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who will undergo elective thoracic surgery including sub-emergency setting
Key exclusion criteria 1)pathological diagnosis of lung cancer, 2)reading disability of Japanese, 3)severe visual disorder, 4)cognitive impairment or impairment of decision-making ability, 5) disease or injury deteriorating QOL significantly, 6)emergency surgery, 7)reoperation for any postoperative complication.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Ichimura
Organization Hitachi Medical Education and Research Center, University of Tsukuba
Division name Department of Thoracic Surgery
Zip code 317-0077
Address 2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL +81-294-23-1111
Email ichimura@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Hideo
Middle name
Last name Ichimura
Organization Hitachi Medical Education and Research Center, University of Tsukuba
Division name Department of Thoracic Surgery
Zip code 317-0077
Address 2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL +81-294-23-1111
Homepage URL
Email ichimura@md.tsukuba.ac.jp

Sponsor
Institute Department of Thoracic Surgery, Hitachi Medical Education and Research Center, University of Tsukuba
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 the ethics review board of the hospital administration headquarters, Hitachi Ltd.
Address 2-1-1 Jyounan, Hitachi, Ibaraki
Tel 0294-23-1111
Email webkanrisha.nichibyo.gd@hitachi.com

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
2015 Year 05 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 207
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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 13 Day
Date of IRB
2015 Year 04 Month 07 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective single-institutional study, In patients fulfilling the criteria, QOL survey will carry out using EQ5D-5L. Survey is scheduled as follows; preoperatively, on postoperative 1, 3, 5, 7-day, 1-month, 1, 2, 3, 5-year. The perioperative survey can be skipped according to the patient's hospital stay. The ambulatory survey can be terminated concurrently with the follow-up termination. This protocol includes malignant tumors like mediastinal tumor, chest wall tumor, and so on.

Management information
Registered date
2015 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020399

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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