UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037666 |
|---|---|
| Receipt number | R000042956 |
| Scientific Title | Retrospective study of surgical management of urachal remnants in children: open versus laparoscopic approach |
| Date of disclosure of the study information | 2019/08/15 |
| Last modified on | 2019/08/12 12:38:55 |
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Basic information
Public title
Retrospective study of surgical management of urachal remnants in children: open versus laparoscopic approach
Acronym
Retrospective study of surgical management of urachal remnants in children: open versus laparoscopic approach
Scientific Title
Retrospective study of surgical management of urachal remnants in children: open versus laparoscopic approach
Scientific Title:Acronym
Retrospective study of surgical management of urachal remnants in children: open versus laparoscopic approach
Region
| Japan |
Condition
Condition
urachal remnants
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparisons between open approach and laparoscopic approach in urachal remnants in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
age at surgery, sex, surgical procedure, total wound length, and length of hospital stay after operation.
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1-15 years old
Key exclusion criteria
Over 16 years old
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | tanaka |
| Middle name | |
| Last name | keiichiro |
Organization
The Jikei University School of Medicine,
Division name
Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo Japan.
TEL
03-3433-1111
keiichiro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | keiichiro |
| Middle name | |
| Last name | tanaka |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery,
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo Japan.
TEL
03-3433-1111
Homepage URL
keiichiro@jikei.ac.jp
Sponsor or person
Institute
Department of Surgery, The Jikei University School of Medicine
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
Department of Surgery, The Jikei University School of Medicine
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo Japan.
Tel
0334331111
keiichiro@jikei.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
| 2019 | Year | 08 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2019 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042956
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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