UMIN-CTR Clinical Trial

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
Last 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
Email	koheiotake@gmail.com

Public contact
1st 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
Email	koheiotake@gmail.com

Sponsor
Institute	Mie Prefectural General Medical Center, Department of Pediatric Surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039073