UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053081 |
|---|---|
| Receipt number | R000060569 |
| Scientific Title | Planned neurectomy for patients with painful inguinal hernia :A prospective cohort study |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/13 12:02:31 |
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Basic information
Public title
Planned neurectomy for patients with painful inguinal hernia :A prospective cohort study
Acronym
Planned neurectomy for patients with painful inguinal hernia :A prospective cohort study
Scientific Title
Planned neurectomy for patients with painful inguinal hernia :A prospective cohort study
Scientific Title:Acronym
Planned neurectomy for patients with painful inguinal hernia :A prospective cohort study
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present prospective study is to evaluate feasibility of planned neurectomy for patients with painful ingunal hernia by means of assessment of pain intensity at 1 year after surgery .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Pain intensity at 1 year after surgery
Key secondary outcomes
1) Numbness
2) Hypersensitivity
3) Unconfortable sensation
4) Pain at ejaculation
5) Pain at erection
6) recurrence
at 1 year after surgery
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
| 16 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with painful inguinal hernia who planned to undergo elective inguinal hernia repair via anterior approach
Key exclusion criteria
1) Emergency surgery
2) Surgery for recurrence or CPIP
3) Laparoscopic hernia repair
4) In case that no consent is obtained from patients
Target sample size
50
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-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
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
6500047
Address
2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
078-302-4321
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city hospital organization certified review board
Address
2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
Tel
078-302-4321
narinari@kuhp.kyoto-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
| 2024 | Year | 01 | Month | 01 | 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
| 2023 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060569
| 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 |
