Ultra Sound in Diagnosis of Acute Abdomen in Pediatric GroupNCT03259048
Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group
An observational study of Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group
- What is being tested?
- Abdominal ultrasound
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- -In this study, 100 patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen.
Who cannot join
- - Patients of age group above 18 years
- Patients with trauma.
Trial locations and contacts
No sites are listed yet.
About this study
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].
Read the 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.
- Being tested
- Abdominal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundDiagnostic test
Abdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group.
| Study group | Role | What they receive |
|---|---|---|
| pediatric group | pediatric group from age of one day to eighteen years. Receives: Diagnostic Test: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of ultrasound in diagnosis of acute abdomen
efficacy of ultrasound in diagnosis of acute abdomen
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra Sound in Diagnosis of Acute Abdomen in Pediatric GroupStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohmed abdelwahab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259048
- Sponsor's protocol ID
- Assiut University Hospitals
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group
- ClinicalTrials.gov ID
- NCT03259048
- Acronym / sponsor ID
- Assiut University Hospitals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric group | – | Diagnostic Test: Abdominal ultrasoundpediatric group from age of one day to eighteen years. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- -In this study, 100 patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen.
Key exclusion criteria (2 listed)
- - Patients of age group above 18 years
- Patients with trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal ultrasoundAbdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group. | Diagnostic test | pediatric group |
Primary outcome
efficacy of ultrasound in diagnosis of acute abdomen
Time frame: 2 years
efficacy of ultrasound in diagnosis of acute abdomen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed abdelwahab (01016307405, mohmed_abdelwahab1011@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of ultrasound in diagnosis of acute abdomen (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.