UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050251 |
|---|---|
| Receipt number | R000057223 |
| Scientific Title | Long term Changes of Activity of Daily Living (ADL) and Health-related Quality of Life (HRQOL) after gastroenterological surgery. |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/02/07 06:57:36 |
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Basic information
Public title
Long term Changes of Activity of Daily Living (ADL) and Health-related Quality of Life (HRQOL) after gastroenterological surgery.
Acronym
Long term Changes of Activity of Daily Living (ADL) and Health-related Quality of Life (HRQOL) after gastroenterological surgery.
Scientific Title
Long term Changes of Activity of Daily Living (ADL) and Health-related Quality of Life (HRQOL) after gastroenterological surgery.
Scientific Title:Acronym
Long term Changes of Activity of Daily Living (ADL) and Health-related Quality of Life (HRQOL) after gastroenterological surgery.
Region
| Japan |
Condition
Condition
digestive diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in ADL and HRQOL score after surgery for digestive diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index, SF-36 subscales and component summary scores before and after surgery (2weeks, 6 and 12 months).
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent elective surgery for digestive diseases in our hospital between 9/1/2017 - 3/30/2028.
Key exclusion criteria
Patients judged as inappropriate for registration by physician.
Target sample size
1900
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Hasegawa |
Organization
Faculty of medicine, Fukuoka University
Division name
Department of Gastroenterological Surgery
Zip code
810-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
0928011011
shase@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Hasegawa |
Organization
Faculty of medicine, Fukuoka University
Division name
Department of Gastroenterological Surgery
Zip code
810-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
0928011011
Homepage URL
shase@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University
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
Medical Ethics Committee of Fukuoka University
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
Tel
0928011011
fumed-ethics@fukuoka-u.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
| 2023 | Year | 02 | Month | 07 | 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
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate changes in ADL and HRQOL indices after digestive surgery and identify risk factors for declining ADL or QOL.
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057223
