UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058610 |
|---|---|
| Receipt number | R000067017 |
| Scientific Title | A prospective, observational study on quality of life 6 months after treatment for chronic postoperative inguinal pain according to the Hernia-Related Quality-of-Life Survey |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/07/27 14:29:13 |
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Basic information
Public title
A prospective, observational study on quality of life 6 months after treatment for chronic postoperative inguinal pain according to the Hernia-Related Quality-of-Life Survey
Acronym
QoL assessment using HerQLes 6 months after CPIP treatment
Scientific Title
A prospective, observational study on quality of life 6 months after treatment for chronic postoperative inguinal pain according to the Hernia-Related Quality-of-Life Survey
Scientific Title:Acronym
QoL assessment using HerQLes 6 months after CPIP treatment
Region
| Japan |
Condition
Condition
Patients with chronic postoperative inguinal pain
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present prospective cohort study is to evaluate quality of life 6 months after treatment for chronic postoperative inguinal pain according to the hernia-related quality-of-life survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A total score of HerQLes 6 months after intiation of treatment for CPIP
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
1) Patients who want to be treated for CPIP
2) Patients who intend to participate the present study
Key exclusion criteria
N/A
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe city Medical Center General Hospital
Division name
Department of Surgery
Zip code
650-0047
Address
2-1-1 Minatojima-minammachi, Chuo-ku
TEL
0783024321
narinari@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe city Medical Center General Hospital
Division name
Department of Surgery
Zip code
650-0047
Address
2-1-1 Minatojima-minammachi, Chuo-ku
TEL
0783024321
Homepage URL
narinari@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe city Medical Center General Hospital
Institute
Department
Personal name
Masato Narita
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city Medical Center General Hospital Clinical and Translational Research Center
Address
2-1-1 Minatojima-minammachi, Chuo-ku
Tel
078-302-4321
rinken@kcho.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
| 2025 | Year | 08 | Month | 30 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 30 | 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
hernia-related quality-of-life survey (HerQLes) is used for assessment of quality of life in patients with CPIP.
Management information
Registered date
| 2025 | Year | 07 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067017
