- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03259048
Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group
August 19, 2017 updated by: mohmed abdelwahab, Assiut University
Acute abdomen can be defined as "A syndrome induced by wide variety of pathological conditions that require emergent medical or more often surgical management" [1].There are a plethora of causes that can lead to acute abdomen in children, they vary depending on the ages of the children and can be divided into diseases that can be treated with medical care and those in which emergency surgical intervention must be considered [2].
Ultrasonography is the initial choice in the diagnosis of the different causes of acute abdomen in children [3, 4].
It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation exposure, as good as laparoscopy, can be done even in patients with scarred abdomen [5].
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
-Patient preparation:
- No specific preparation is needed.
- Demographic data including age, sex, detailed history, clinical presentation, laboratory tests, and data of any other investigations or operation will be obtained.
Clinical examination will be done in emergency pediatric unit for provisional diagnosis.
-Study instruments:• Patients will examined by Grey-Scale Ultrasonography (U/S) combined with Color Doppler Ultrasonography (CDUS).
3-Technique of examination
- will be in supine position.
- Patient First examination of whole abdomen will be done by Grey -Scale U/S using both 3.5 MHZ and 7.5 MHZ transducers .It will be done in both longitudinal ( parallel to long axis of the patient ) and transverse ( perpendicular to long axis of the patient ) orientation .
- Then finally examination by Color Doppler US will be done for assessment of organ perfusion and diagnosing inflammation.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen from age of 1 day to 18 years.
Description
Inclusion Criteria:
- -In this study, 100 patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen.
Exclusion Criteria:
- - Patients of age group above 18 years
- Patients with trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pediatric group
pediatric group from age of one day to eighteen years.
|
Abdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy of ultrasound in diagnosis of acute abdomen
Time Frame: 2 years
|
efficacy of ultrasound in diagnosis of acute abdomen
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2017
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
August 19, 2017
First Submitted That Met QC Criteria
August 19, 2017
First Posted (Actual)
August 23, 2017
Study Record Updates
Last Update Posted (Actual)
August 23, 2017
Last Update Submitted That Met QC Criteria
August 19, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Assiut University Hospitals
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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