UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single-institution database creation and analysis of the patients with pediatric surgical diseases for the improvement of the quality of medical care
Title of the study (Brief title)	A single-institution database creation and analysis of pediatric surgical diseases
Region	Japan

Condition
Condition	All pediatric surgical diseases including malignancy
Classification by specialty	Surgery in general Child
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	0 years-old <=
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	14000

Research contact person
Name of lead principal investigator	Keiichi Uchida
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL	059-232-1111(5645)
Email	ucchie@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Keiichi Uchida
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL	059-232-1111(5645)
Homepage URL
Email	ucchie@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	三重大学病院（三重県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective and retrospective observational study

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2017 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025352