UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028859 |
|---|---|
| Receipt number | R000032929 |
| Scientific Title | A prospective multicenter randomized controlled trial for the effect of compression therapy for umbilical hernia |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2024/03/03 23:17:30 |
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Basic information
Public title
A prospective multicenter randomized controlled trial for the effect of compression therapy for umbilical hernia
Acronym
A trial for the effect of compression therapy for umbilical hernia
Scientific Title
A prospective multicenter randomized controlled trial for the effect of compression therapy for umbilical hernia
Scientific Title:Acronym
A trial for the effect of compression therapy for umbilical hernia
Region
| Japan |
Condition
Condition
umbilical hernia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, indication and influence on appearance of compression therapy for umbilical hernia by prospective multicenter randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of protruding umbilicus at one year.
Key secondary outcomes
The presence of umbilical hernia at 3 months, 6 months and 9 months from the start of treatment, and at one year.
The presence of dermatitis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Compression by cotton ball
Interventions/Control_2
No intervention
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
| 2 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonates who was detected umbilical hernia at postnatal examination or presented to collaborating research institute by introduction.
Key exclusion criteria
Patients who had chromosomal abnormalities, surgical diseases, malformations. Patients with bad skin conditions around the umbilicus. Patients who had some intervention to umbilical hernia before one month postnatal examination. Patients whose parents do not agree to participate in this study. Premature infant.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kidokoro |
Organization
Nagoya University Hospital
Division name
Department of Pediatrics
Zip code
466-8560
Address
65 Tsurumai-cho Showa-ku, Nagoya 466-8560, Japan
TEL
+81-(0)52-744-2294
kidokoro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Azuma |
| Middle name | |
| Last name | Ikari |
Organization
Nagoya University Hospital
Division name
Department of Pediatrics
Zip code
466-8560
Address
65 Tsurumai-cho Showa-ku, Nagoya 466-8560, Japan
TEL
+81-(0)52-744-2294
Homepage URL
ikari_azuma@yahoo.co.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Department of Pediatrics
Address
65 Tsurumai-cho Showa-ku, Nagoya 466-8560, Japan
Tel
+81-(0)52-744-2294
kidokoro@med.nagoya-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 28 | 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
129
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032929
