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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033936
Receipt No. R000038703
Scientific Title A prospective nationwide survey of postoperative chronic pain following inguinal hernia repair in Japan
Date of disclosure of the study information 2018/08/29
Last modified on 2019/04/24

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Basic information
Public title A prospective nationwide survey of postoperative chronic pain following inguinal hernia repair in Japan
Acronym Japanese nationwide survey of postoperative chronic pain following inguinal hernia repair
Scientific Title A prospective nationwide survey of postoperative chronic pain following inguinal hernia repair in Japan
Scientific Title:Acronym Japanese nationwide survey of postoperative chronic pain following inguinal hernia repair
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 this prospective cohort study is to clarify the frequency of and risk factors for postoperative chronic pain at 3 months after inguinal hernia repair in Japan.
Basic objectives2 Others
Basic objectives -Others Secondary endpoint is to investigate change over time of pain, collateral symptoms, and therapeutic course in patients with moderate or severe pain. Frequency of hernia recurrence, complication, and re-admission are also evaluated.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of and risk factor for postoperative moderate or severe chronic pain (NRS 4 or more) at 3 months after inguinal hernia repair
Key secondary outcomes 1. Change over time of degree of chronic pain
2. Treatment details of postoperative chronic pain
3. Presence of a foreign body sensation, paresthesia, and sexual pain
4. Frequency of hernia recurrence, complication, and re-admission

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. 20 years or more
2. Elective surgery for inguinal hernia
3. Patients who can have outpatient visit at 3 months after surgery
4. Patients who can make their own decision to participate this study
Key exclusion criteria 1. Emergent surgery
2. Surgery for relapse or chronic pain
3. Femoral hernia case
4. Patients who cannot express their pain
Target sample size 1600

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Narita
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Surgery
Zip code 642-8555
Address 1-1 Fukakusa-mukaihata-cho, Fushimi-ku 6128555 Kyoto city
TEL +81756419161
Email narinari@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Narita
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Surgery
Zip code 612-8555
Address 1-1 Fukakusa-mukaihata-cho, Fushimi-ku 6128555 Kyoto city
TEL +81756419161
Homepage URL
Email hernia_study@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka south medical center
Sendai medical center
Kyushu medical center
Yonago medical center
Takasaki medical center
Nagoya medical center
Tsuruga medical center
Osaka medical center
Kure medical center
Kagoshima medical center
Shiroyama hospital
Himeji medical center
Tokyo medical center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of National Hospital Organization
Address 2-5-21 Higachigaoka, Meguro-ku, Tokyo
Tel 03-5712-507
Email 700-kenkyu@mail.hosp.go.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 米子医療センター     
高崎総合医療センター   
名古屋医療センター    
敦賀医療センター     
大阪医療センター     
呉医療センター      
鹿児島医療センター    
春秋会城山病院      
姫路医療センター     
東京医療センター   

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 29 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
2018 Year 08 Month 28 Day
Date of IRB
2018 Year 08 Month 29 Day
Anticipated trial start date
2018 Year 08 Month 29 Day
Last follow-up date
2023 Year 08 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Primary endpoint
Frequency of and risk factor for postoperative moderate or severe chronic pain (NRS 4 or more) at 3 months after inguinal hernia repair

Secondary endpoint
1. Change over time of degree of chronic pain
2. Treatment details of postoperative chronic pain
3. Presence of a foreign body sensation, paresthesia, and sexual pain
4. Frequency of hernia recurrence, complication, and re-admission

Management information
Registered date
2018 Year 08 Month 29 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038703

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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