UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005470
Receipt No. 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 2018/10/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Seiichiro Inoue
Organization Saitama medical center, Saitama Medical University
Division name Hepato-biliary-pancreatic suregry and Pediatric surgery
Zip code
Address Kamoda 1981, Kawagoe, Saitama pref. 3508550, Japan
TEL 0492283400
Email sei_khsr@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichiro Inoue
Organization Saitama medical center, Saitama Medical University
Division name Hepato-biliary-pancreatic suregry and Pediatric surgery
Zip code
Address Kamoda 1981, Kawagoe, Saitama pref. 3508550, Japan
TEL 049-228-3400
Homepage URL
Email sei_khsr@saitama-med.ac.jp

Sponsor
Institute Hepato-biliary-pancreatic suregry and Pediatric surgery, Saitama medical center, Saitama Medical University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2010 Year 05 Month 10 Day
Date of IRB
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
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.