UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061149 |
|---|---|
| Receipt number | R000069975 |
| Scientific Title | Nationwide multicenter retrospective study of mesh infection after inguinal hernia repair in Japan |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/03 12:47:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nationwide multicenter retrospective study of mesh infection after inguinal hernia repair in Japan
Acronym
JHS-MI Study
Scientific Title
Nationwide multicenter retrospective study of mesh infection after inguinal hernia repair in Japan
Scientific Title:Acronym
JHS-MI Study
Region
| Japan |
Condition
Condition
Mesh infection after inguinal hernia repair
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively collect and analyze multicenter clinical data on mesh infection after inguinal hernia repair in Japan, and to clarify the proportion of patients requiring mesh removal, the incidence of mesh infection, the interval from initial surgery to diagnosis, causative organisms, treatment outcomes, and hernia recurrence.
Basic objectives2
Others
Basic objectives -Others
Registry and outcome analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients with mesh infection after inguinal hernia repair who required mesh removal during the treatment course.
Key secondary outcomes
Incidence of mesh infection during the study period
Interval from initial hernia repair to diagnosis of mesh infection
Causative microorganisms
Differences in outcomes between total mesh removal and partial mesh removal, including postoperative complication rates and infection recurrence
Time to clinical cure of mesh infection
Hernia recurrence rate and recurrence pattern after mesh removal
All secondary outcomes will be assessed up to the last follow-up.
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. Age 18 years or older
2. Patients who underwent mesh-based inguinal hernia repair at participating institutions between January 1, 2015 and June 30, 2025, or patients who received treatment for mesh infection after inguinal hernia repair during the same period
3. Written informed consent obtained or opt-out procedure completed
Key exclusion criteria
1. Cases without mesh implantation
2. Cases with less than 90 days of adequate follow-up after inguinal hernia repair
3. Cases judged inappropriate for inclusion by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Gakuhara |
Organization
Kindai University Nara Hospital
Division name
Department of Gastroenterological Surgery
Zip code
630-0293
Address
1248-1 Ototacho, Ikoma, Nara 630-0293, Japan
TEL
+81-743-77-0880
agakuhara@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhito |
| Middle name | |
| Last name | Suwa |
Organization
Japanese hernia society
Division name
Project committees
Zip code
112-0012
Address
Association for Supporting Academic Societies, 5-3-13 Otuka, Bunkyo-ku, Tokyo 112-0012, Japan
TEL
+81-3-5981-6011
Homepage URL
jhs0601@asas-mail.jp
Sponsor or person
Institute
Kindai University Nara Hospital
Institute
Department
Personal name
Atsushi Gakuhara
Funding Source
Organization
Japanese Hernia Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kindai University Nara Hospital
Address
1248-1 Ototacho, Ikoma, Nara 630-0293, Japan
Tel
+81-743-77-0880
agakuhara@med.kindai.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
| 2026 | Year | 04 | 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
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a nationwide multicenter retrospective cohort study conducted as a project study of the Japanese Hernia Society. Eligible patients include those who underwent mesh-based inguinal hernia repair at participating institutions between January 1, 2015 and June 30, 2025, as well as those who received treatment for mesh infection after inguinal hernia repair during the same period. The primary outcome is the proportion of mesh infection cases requiring mesh removal. Secondary outcomes include the incidence of mesh infection, interval from initial hernia repair to diagnosis, causative microorganisms, differences in outcomes between total and partial mesh removal, time to clinical cure, and hernia recurrence. Mesh infection is defined as cases clinically diagnosed by the attending physician based on infectious signs and imaging findings. Early infection is defined as onset within 90 days after the initial surgery, and delayed infection as onset more than 90 days after surgery. Data will be collected through SurveyMonkey and centrally analyzed.
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069975
