UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016983 |
|---|---|
| Receipt number | 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 | 2021/10/09 18:51:18 |
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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
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
hiro2013@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 08 | 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
| 2021 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019025
