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Trial registered on ANZCTR


Registration number
ACTRN12610000967088
Ethics application status
Approved
Date submitted
30/10/2010
Date registered
10/11/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
ketonuria in acute abdomen of preschool children without a history of diabetes mellitus
Scientific title
Frequency of ketonuria in the acute abdomen of preschool children without a history of diabetes mellitus - a diagnostic study
Secondary ID [1] 252990 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
appendicitis in preschool children 258527 0
Condition category
Condition code
Oral and Gastrointestinal 258686 258686 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
urinalysis in emergency room as initial laboratory (within 1 hour after visiting emergency room)
Intervention code [1] 257511 0
Not applicable
Comparator / control treatment
Author collected data in gastroenteritis and colitis ( who needed admission), May 2004 to July 2010. Then other( nurse ) had collected comparator according to inclusional criteria, urinalysis was done with first voiding urine in emergency room and no history of diabetes mellitus and preschool children, and counts of comparator initially were more than 2 perons than one of each age and each sex of appendicitis. Then author removed inadequate cases, so final comparator was 99 cases.
Control group
Historical

Outcomes
Primary outcome [1] 259546 0
frequency of ketonuria in appendicitis and comparator were 55/79 (69.6%) and 52/99 (52.5%)
Timepoint [1] 259546 0
immediately after baseline
Secondary outcome [1] 266164 0
nil
Timepoint [1] 266164 0
nil

Eligibility
Key inclusion criteria
1. preschool children
2. did urinalysis with first voiding urine in emergency room
3. no history of diabetes mellitus
4. confirmed appendicitis
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. history of diabetes mellitus
2. urinalysis was done at other place or not first voiding urine
3. urinalysis was done after a period of observation to do repeated examination
4. no urinalysis
5. negative appendectomy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
178
Accrual to date
Final
Recruitment outside Australia
Country [1] 3010 0
Korea, Republic Of
State/province [1] 3010 0

Funding & Sponsors
Funding source category [1] 257963 0
Other
Name [1] 257963 0
SeongRyul Ryu
Country [1] 257963 0
Korea, Republic Of
Primary sponsor type
Other
Name
SeongRyul Ryu
Address
Samsung Changwon Hospital, Hapsung 2-dong Changwon, 630-723
Country
Korea, Republic Of
Secondary sponsor category [1] 257209 0
None
Name [1] 257209 0
Address [1] 257209 0
Country [1] 257209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259973 0
Samsung Changwon Hospital IRB (institutional review board)
Ethics committee address [1] 259973 0
Samsung Changwon Hospital, Hapsung 2-dong Changwon, 630-723
Ethics committee country [1] 259973 0
Korea, Republic Of
Date submitted for ethics approval [1] 259973 0
06/10/2010
Approval date [1] 259973 0
21/10/2010
Ethics approval number [1] 259973 0
2010-SCMC-037-00

Summary
Brief summary
The preschool children have had problem in diagnosis of appendicitis because of poor history taking and inappropriate response to physical examination. The leukocytosis with differential counts or C reactive protein as indicators of inflammation were not to predict further invasive evaluation like immediate computed tomography or intraabdominal sonography in acute abdomen.
The hyperketonemia without past history of diabetes mellitus have been used a indicator to decide severity of illness for admission and treatment.
So ketonuria was not qualified test for ketoacidosis, but it might be helpful.
Therefore if preschool child had positive ketonuria and abdominal pain, then immediate computed tomography or abdominal ultrasonography should be done to rule out surgical diseases like appendicitis. And urinalysis should be absolutely neccesory procedure in emergency room.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31851 0
Address 31851 0
Country 31851 0
Phone 31851 0
Fax 31851 0
Email 31851 0
Contact person for public queries
Name 15098 0
SeongRyul Ryu, M.D.
Address 15098 0
Samsung Changwon Hospital, Hapsung 2-dong, Changwon, 630-723
Country 15098 0
Korea, Republic Of
Phone 15098 0
82-10-6335-6222
Fax 15098 0
82-55-290-6584
Email 15098 0
[email protected]
Contact person for scientific queries
Name 6026 0
SeongRyul Ryu, M.D.
Address 6026 0
Samsung Changwon Hospital, Hapsung 2-dong, Changwon, 630-723
Country 6026 0
Korea, Republic Of
Phone 6026 0
82-10-6335-6222
Fax 6026 0
82-55-290-6584
Email 6026 0
[email protected]

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