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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016983
Receipt No. R000019025
Scientific Title The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Date of disclosure of the study information 2015/04/01
Last modified on 2015/11/11

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Basic information
Public title The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Acronym The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Scientific Title The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Scientific Title:Acronym The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Region
Japan

Condition
Condition esophageal atresia, esophageal stenosis
, pleuroperitoneal hiatus hernia, acute or chronic renal failure, omental cyst or mesenterium cystoma, choledochal cyst, biliary atresia, pancreas tumor, pancreas head region tumor, acute or chronic pancreatitis, pancreatic lithiasis, intussusception, hypersplenism, splenic injury, sacrococcygeal teratoma, vesicoureteral reflux
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The prospective study for safety and efficacy of the pediatirc endoscopic operations which are not published by a fee-for service list
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)operative time, 2)operative blood loss, 3)open conversion, 4)intra-, post-operative complication, 5)reoperation, 6)post-operative length of stay, 7)surgery-related death, 8)long-term outcome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 the pediatric endoscopic operations which are not published by a fee-for-service list
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.diseases targeted for this study
2.operative treatment is generally proven as an effective treatment
3.A written informed consent is obtained in this study
4.exception to exclusion criterion
Key exclusion criteria 1.no consent for this study
2.in case we judge the endoscopic operation could not be applied
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Uchida
Organization Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name Pediatric Surgery
Zip code
Address 65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL 052-744-2959
Email hiro2013@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroo Uchida
Organization Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name Pediatric of Surgery
Zip code
Address 65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL 052-744-2959
Homepage URL
Email hiro2013@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋大学 医学部 附属病院 (愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 31 Day
Last modified on
2015 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019025

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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