UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033936 |
|---|---|
| Receipt number | 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 | 2021/10/25 09:30:09 |
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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
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
hernia_study@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yonago medical center
Tsuruga medical center
Sendai medical center
Beppu medical center
Ureshino medical center
Fukuoka east medical center
Kyushu medical center
Osaka medical center
Kure medical center
Hakodate hospital
Takasaki medical center
Nagoya medical center
Himeji medical center
Kagoshima medical center
Osaka medical center
Tokyo medical center
Shiroyama hospital
JA Hiroshima General Hospital
Seirei Hamamatsu General Hospital
Osaka Rosai Hospital
Takamatsu Red Cross Hospital
Okayama Red Cross Hospital
Hiratsuka City Hospital
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
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
京都医療センター
米子医療センター
敦賀医療センター
仙台医療センター
別府医療センター
嬉野医療センター
福岡東医療センター
九州医療センター
大阪南医療センター
呉医療センター
函館病院
高崎総合医療センター
名古屋医療センター
姫路医療センター
鹿児島医療センター
大阪医療センター
東京医療センター
城山病院
JA広島総合病院
聖隷浜松病院
大阪労災病院
高松赤十字病院
岡山赤十字病院
平塚市民病院
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
2804
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
No longer recruiting
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 | 04 | Month | 30 | 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
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038703
| Research Plan | |
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| 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 |
