UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034273 |
|---|---|
| Receipt number | R000039073 |
| Scientific Title | A single-institution database creation and analysis of the patients with pediatric surgical diseases for the improvement of the quality of medical care |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/04/24 17:03:29 |
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Basic information
Public title
A single-institution database creation and analysis of the patients with pediatric surgical diseases for the improvement of the quality of medical care
Acronym
A single-institution database creation and analysis of pediatric surgical diseases
Scientific Title
A single-institution database creation and analysis of the patients with pediatric surgical diseases for the improvement of the quality of medical care
Scientific Title:Acronym
A single-institution database creation and analysis of pediatric surgical diseases
Region
| Japan |
Condition
Condition
All pediatric surgical diseases including patients aged over 15 years
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To improve the quality of medical care in pediatric surgery, we build a single-institution patient database of pediatric surgical diseases comprehensively and analyze the clinical data.
Basic objectives2
Others
Basic objectives -Others
Surgical outcome, complication, effect, clinical data, hospital stay, outcome of rare disease
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis
Key secondary outcomes
Surgical outcome, complication, effect, clinical data, hospital stay
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. All patients with pediatric surgical disease, visiting our outpatient clinic or hospitalized in our institute.
2. All patients are required to give written informed consent prior to enrolment in the study.
3. Patients who are under 10 years old are required to give written informed consent from proxy.
4. Patients who are aged over 10 years and below 20 years are required to give written informed assent and written informed consent from proxy.
Key exclusion criteria
Patients whom investigators consider to be ineligible
Target sample size
4900
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Otake |
Organization
Mie Prefectural General Medical Center
Division name
Department of Pediatric Surgery
Zip code
510-8561
Address
5450-132 Hinaga, Yokkaichi, Mie 510-8561, Japan
TEL
059-345-2321
koheiotake@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Otake |
Organization
Mie Prefectural General Medical Center
Division name
Department of Pediatric Surgery
Zip code
510-8561
Address
5450-132 Hinaga, Yokkaichi, Mie 510-8561, Japan
TEL
059-345-2321
Homepage URL
koheiotake@gmail.com
Sponsor or person
Institute
Mie Prefectural General Medical Center, Department of Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
Mie Prefectural General Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Mie Prefectural General Medical Center
Address
5450-132 Hinaga, Yokkaichi, Mie 510-8561, Japan
Tel
059-345-2321
kenkyu@mie-gmc.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
三重県立総合医療センター（三重県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039073
| Research Plan | |
|---|---|
| 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 |
