UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042636 |
|---|---|
| Receipt number | R000048653 |
| Scientific Title | Patient reported outcome of the quality of life after surgery and establishment of the feedback system: an implementary research. |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2021/06/04 09:52:05 |
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Basic information
Public title
Patient reported outcome of the quality of life after surgery and establishment of the feedback system: an implementary research.
Acronym
POLITE RESEARCH
Scientific Title
Patient reported outcome of the quality of life after surgery and establishment of the feedback system: an implementary research.
Scientific Title:Acronym
POLITE RESEARCH
Region
| Japan |
Condition
Condition
Various diseases related to Surgery
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to elucidate utility of the QOL after surgery and build a standard platform for Health Technology Assessment (HAT).
Basic objectives2
Others
Basic objectives -Others
Assessment of the QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D-5L
HADS (Hospital Anxiety Depression Scale)
Key secondary outcomes
BREAST-Q
FACT-Hep
FACT-C
FACT-L
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled for gastrointestinal surgery, breast surgery, and respiratory surgery
2) The person or family is convinced about participating in the research and can answer the questionnaire.
Key exclusion criteria
1) Cases in which it is difficult to fill out and enter questionnaires by the person due to problems with cognitive function, etc.
2) Patients who do not own devices such as smartphones, tablets, and PCs and cannot answer ePRO (electronic questionnaire) at home
3) In addition, when the doctor in charge judges that the registration of this study is inappropriate
Target sample size
13000
Research contact person
Name of lead principal investigator
| 1st name | MIZUGUCHI |
| Middle name | |
| Last name | TORU |
Organization
SAPPORO MEDICAL UNIVERSITY
Division name
Department of Nursing, Surgical science & Technology
Zip code
0608556
Address
S1, W17, Chuo-ku, Sapporo, Hokkaido 0608556, JAPAN
TEL
0116112111
tmizu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | MIZUGUCHI |
| Middle name | |
| Last name | TORU |
Organization
SAPPORO MEDICAL UNIVERSITY
Division name
Department of Nursing, Surgical science & Technology
Zip code
0608556
Address
S1, W17, Chuo-ku, Sapporo, Hokkaido 0608556, JAPAN
TEL
0116112111
Homepage URL
tmizu@sapmed.ac.jp
Sponsor or person
Institute
SAPPORO MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Hospital, Clinical Research Review Committee
Address
291, S1, W16, Chuo-Ku, Sapporo, Hokkaido 0608543, JAPAN
Tel
0116112111
ji-rskk@sapmed.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
札幌医科大学附属病院（北海道）、JR札幌病院（北海道）・札幌道都病院（北海道）・東札幌病院（北海道）・ことに乳腺クリニック（北海道）・札幌乳腺クリニック（北海道）・東邦大学大橋病院（東京都）・昭和大学附属病院（東京都）・日本医科大学付属病院（東京都）・旭川医科大学病院（北海道）・三重大学医学部附属病院（三重県）・根室市立病院（北海道）・札幌里塚病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 05 | 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
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048653
| 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 |
