UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028759 |
|---|---|
| Receipt number | R000032909 |
| Scientific Title | A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2024/10/04 17:28:09 |
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Basic information
Public title
A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan
Acronym
A prospective study of chronic postsurgical pain in Japan
Scientific Title
A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan
Scientific Title:Acronym
A prospective study of chronic postsurgical pain in Japan
Region
| Japan |
Condition
Condition
Malignant lung tumor
Osteoarthritis
Rheumatoid arthritis
Classification by specialty
| Chest surgery | Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective multicenter study to confirm the prevalence and risk factors of chronic postsurgical pain after lung cancer surgery and TKA in Japan.
Basic objectives2
Others
Basic objectives -Others
a prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of postsurgical pain 3 months and 6 months after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were scheduled lung cancer surgery or TKA during the case registration periods.
Key exclusion criteria
Patients who had other surgeries within 3 months.
Surgery of both sides of lung or knee.
Patients who cannot answer the questions written in Japanese.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | YOKO |
| Middle name | |
| Last name | Sugiyama |
Organization
Gifu university
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagito Gifu city Gifu
TEL
058-230-6404
yoko_sg@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | YOKO |
| Middle name | |
| Last name | Sugiyama |
Organization
Gifu university
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagito Gifu city Gifu
TEL
058-230-6404
Homepage URL
yoko_sg@gifu-u.ac.jp
Sponsor or person
Institute
Gifu university graduate school of medicine Department of Anesthesiology and Pain Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Gifu university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinshu university, Toyama university, Teikyo university, The Jikei university, Juntendo university, Tottori university, Aichi medical university, Osaka university, Yokohama city university, Kawasaki medical school, Wakayama medical university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu university graduate school of medicine IRB
Address
1-1 Yanagido Gifu city, Gifu, JAPAN
Tel
058-230-6059
rinri@gifu-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
| 2017 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Collecting data:
Pain intensity (NRS) at rest/with movement 1day, 7days, 1month, 3 and 6 months after surgery. DN4 score, QOL score, HADS score, used analgesics, smoking status, radiation or chemotherapy, surgical procedure, anesthetic methods, demographic data
Primary endpoint: the prevalence of postsurgical pain at 3 and 6months after surgery.
Secondary endpoint: risk factors of chronic postsurgical pain
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032909
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/07/10 | 観察研究_研究計画書final.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/07/10 | データシート 膝関節置換術 8-24-17.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/10/04 | ★★★multicenter prospect CPSP lung final.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/32909
