UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056082 |
|---|---|
| Receipt number | R000064083 |
| Scientific Title | Determining the Minimum Clinically Important Difference for the Japanese versions of the European Hernia Society Quality of Life Instrument in Abdominal Hernia Repair Patients: Multi-center prospective study |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 22:05:48 |
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Basic information
Public title
Determining the Minimum Clinically Important Difference for the Japanese versions of the European Hernia Society Quality of Life Instrument in Abdominal Hernia Repair Patients
Acronym
Survey on Quality of Life of Abdominal Hernia
Scientific Title
Determining the Minimum Clinically Important Difference for the Japanese versions of the European Hernia Society Quality of Life Instrument in Abdominal Hernia Repair Patients: Multi-center prospective study
Scientific Title:Acronym
Determining the Minimum Clinically Important Difference for the Japanese versions of the European Hernia Society Quality of Life Instrument in Abdominal Hernia Repair Patients(Hernia-QoL JMU study)
Region
| Japan |
Condition
Condition
abdominal hernia repair patients
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the minimum clinically important difference for the Japanese version of the European Hernia Society Quality of Life instrument in abdominal hernia repair patients
Basic objectives2
Others
Basic objectives -Others
To determine the minimum clinically important difference for the Japanese version of the European Hernia Society Quality of Life instrument in abdominal hernia repair patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the minimum clinically important difference for the Japanese version of the European Hernia Society Quality of Life instrument
Key secondary outcomes
Minimum Clinically Significant Difference in Pain Domain of EuraHS-QoL Japanese version
Minimal clinically important difference in the activity limitation domain of the EuraHS-QoL Japanese version
Minimal clinically important difference in the Tolerance domain of the EuraHS-QoL Japanese version
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Men and women who are at least 18 years of age at the time of surgery
(2) American Society of Anesthesiologists-physical status I-III
(3) Native speaker of Japanese
Key exclusion criteria
(1) Persons who refuse to give their consent
(2) Persons whose ability to answer questions is limited by cognitive or physical conditions
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Jichi Medical University
Division name
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL
0285442111
m06105jw@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Jichi Medical University
Division name
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL
0285442111
Homepage URL
m06105jw@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Self finding
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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
Tel
0285442111
m06105jw@jichi.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
| 2024 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No.24-059
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064083
