UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038930 |
|---|---|
| Receipt number | R000044356 |
| Scientific Title | epidemiology of Post-craniotomy headache (EPoCH) |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2023/12/22 12:37:13 |
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Basic information
Public title
epidemiology of Post-craniotomy headache (EPoCH)
Acronym
epidemiology of Post-craniotomy headache (EPoCH)
Scientific Title
epidemiology of Post-craniotomy headache (EPoCH)
Scientific Title:Acronym
epidemiology of Post-craniotomy headache (EPoCH)
Region
| Japan |
Condition
Condition
post-craniotomy
Classification by specialty
| Neurosurgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this retrospective study is to clarify epidemiology, symptom, risk factor, clinical course, therepeutic effect and prognosis of post-craniotomy headache.
Basic objectives2
Others
Basic objectives -Others
We will try to establish the concept of this clinical entity, diagnosis and prevention methods.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of post-craniotomy headache
Key secondary outcomes
Patients factor
craniotomy
frequency and severity of post-craniotomy headache
Therapeutic effects
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
| 6 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients who received suboccipital craniotomy surgery in recent 5 years, and followed more than 6 months.
Key exclusion criteria
Patients who has chronic headache before craniotomy surgery.
Surgical Complication.
Worsening of original diseases.
Disturbance of consciousness or speech.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center
Division name
Neurosurgery
Zip code
3100015
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
TEL
+81292312371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center
Division name
Neurosurgery
Zip code
3100015
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
TEL
+81292312371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Mito Medical Center
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Mito Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
University of Tsukuba, and other
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Mito Medical Center
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
Tel
+81292312371
yshibata@md.tsukuba.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
筑波大学 水戸地域医療教育センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35191330/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35191330/
Number of participants that the trial has enrolled
311
Results
A total of 145 patients (49%) experienced post-craniotomy headaches. Microvascular decompression surgery, craniectomy and facial spasms were significant risk factors for post-craniotomy headaches. In most cases, the post-craniotomy headaches disappeared within one month; however, some patients suffered from long-term headaches.
Results date posted
| 2023 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
suboccipital craniotomy
Participant flow
follow up more than 6 months
Adverse events
N/A
Outcome measures
headache
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One, 3 and 6 months after craniotomy surgery is predetermined recommended observation timing.
Management information
Registered date
| 2019 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044356
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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