UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017597 |
|---|---|
| Receipt number | 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 | 2023/11/20 09:52:40 |
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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
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
ichimura@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Hitachi Medical Education and Research Center, University of Tsukuba
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
the ethics review board of the hospital administration headquarters, Hitachi Ltd.
Address
2-1-1 Jyounan, Hitachi, Ibaraki
Tel
0294-23-1111
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
207
Results
A prospective single-center study of patient-reported outcomes (PRO) in respiratory surgery patients excluding lung cancer was conducted.
A comparison of PRO/quality of life between pleural coverage and pleurectomy in spontaneous pneumothorax surgery was analyzed and published.
Results date posted
| 2023 | Year | 11 | Month | 20 | Day |
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
Completed
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 | 11 | Month | 20 | 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
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020399
| 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 |
