UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006331 |
|---|---|
| Receipt number | R000007510 |
| Scientific Title | Prospective study of contraternal inguinal hernia in chidren with ultrasonography |
| Date of disclosure of the study information | 2011/09/12 |
| Last modified on | 2015/03/12 12:11:04 |
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Basic information
Public title
Prospective study of contraternal inguinal hernia in chidren with ultrasonography
Acronym
Prospective study of contraternal inguinal hernia in chidren
Scientific Title
Prospective study of contraternal inguinal hernia in chidren with ultrasonography
Scientific Title:Acronym
Prospective study of contraternal inguinal hernia in chidren
Region
| Japan |
Condition
Condition
inguinal hernia in children
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficay of the US for the contralateral inguinal hernia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocurrence of the contralateral inguinal hernia
Key secondary outcomes
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children
Key exclusion criteria
Parents do not agree with this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiminobu Sugito |
Organization
Nihon University, School of Medicine
Division name
Pediatric surgery
Zip code
Address
30-1, Ohyaguchi Kamicho, Itabashiku, Tokyo, Japan
TEL
03-3972-8111
sugitou.kiminobu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiminobu Sugito |
Organization
Nihon University, School of Medicine
Division name
Pediatric Surgery
Zip code
Address
30-1, Ohyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan
TEL
03-3972-8111
Homepage URL
sugitou.kiminobu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University, School of Medicine
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
now, obserbation period
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
| 2011 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
on going
Management information
Registered date
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2015 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007510
