UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005470 |
|---|---|
| Receipt number | R000006478 |
| Scientific Title | Analysis ofrelation between Mycoplasma Pneoumoniae infection and acute appendicitis in chldren |
| Date of disclosure of the study information | 2011/04/25 |
| Last modified on | 2021/04/26 17:29:13 |
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Basic information
Public title
Analysis ofrelation between Mycoplasma Pneoumoniae infection and acute appendicitis in chldren
Acronym
Impact of Mycoplasma infection for acute appendicitis in chldren
Scientific Title
Analysis ofrelation between Mycoplasma Pneoumoniae infection and acute appendicitis in chldren
Scientific Title:Acronym
Impact of Mycoplasma infection for acute appendicitis in chldren
Region
| Japan |
Condition
Condition
Acute appendicitis
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of M.Pneoumonia infection to acute appendicitis in Children
Basic objectives2
Others
Basic objectives -Others
Observation study; to
detect M. Pneoumonia infection in childre who diagnosed acute appendicitis without respiratory tract symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring anti-M.Pneoumonia IgM antibody.
Detect of M.Pneoumonia infection in appendix which surgically resected, using PCR technique.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Children who diagnosed acute appendicitis(from 1 to less than 14 year old):
measuring anti M. Pneoumonia IgM antibody (two times)
PCR using the resected appendix.
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
| 1 | years-old | <= |
Age-upper limit
| 14 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children who admitted to our center with the chief complain of right lower quadrant pain, and also detected the swelling of appendix by CT.
Key exclusion criteria
Patients who and/or whose family refuses to admit this reaearch.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Inoue |
Organization
Saitama medical center, Saitama Medical University
Division name
Hepato-biliary-pancreatic suregry and Pediatric surgery
Zip code
3508550
Address
Kamoda 1981, Kawagoe, Saitama pref. 3508550, Japan
TEL
0492283400
yuta_t@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University,
Division name
Hepato-biliary-pancreatic suregry and Pediatric surgery
Zip code
3508550
Address
Kamoda 1981, Kawagoe, Saitama pref. 3508550, Japan
TEL
049-228-3400
Homepage URL
takmu@saitama-med.ac.jp
Sponsor or person
Institute
Hepato-biliary-pancreatic suregry and Pediatric surgery, Saitama medical center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical Center, Saitama Medical University
Address
Kamoda1981 Kawagoe city
Tel
0492283400
sei_khsr@saitama-med.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
| 2011 | Year | 04 | Month | 25 | 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
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
Storing the blood samples and some parts of appendix which surgically resected.
Management information
Registered date
| 2011 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
