Acute Abdomen in ChildrenNCT04480983
Role of Multidetector Computerized Tomography (MDCT) in Diagnosis of Non Traumatic Acute Abdomen in Pediatric Age Group.
An observational study of Acute Abdomen in Children, run by Amal Fathy Abo Elgarad.
Trial summary
To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Acute Abdomen in Children
- What is being tested?
- Multidetector Computerized Tomography (MDCT)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jan 2023
- 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 15 years
- All sexes
- Child
Study population: The role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
Who may be able to join
- Patients presented by acute abdominal pain from first day of life till fifteen years old.
Who cannot join
- Patients above 15 years old.
- Patients with traumatic cause of acute abdominal pain.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
Read the detailed description
Acute abdominal pain is a common presenting symptom to the pediatric emergency department (1). The causes of the acute abdomen in pediatric patients are numerous, and diagnosis is often delayed due to misleading signs and symptoms.
Conditions that can be manifested by acute abdominal pain vary in incidence with age and sex. Classification of acute abdominal pain based on age is one adapted approach to narrow the differential diagnosis, which can guide selection of appropriate diagnostic tests, imaging, and definitive treatment.
While most of the emergency visits presenting with acute abdominal pain are self-limited and benign medical diagnoses, a surgical etiology may be present in up to 20%.(7) In nontraumatic cases of an acute abdomen below 1 year of age, the most common surgical etiology was reported to be incarcerated inguinal hernia (45.1%), followed by intussusception (41.9%). These etiologies were uncommon in school-age and adolescent children. In children above 1 year of age, the most common causes of acute surgical diagnoses have been reported to be acute appendicitis , incarcerated hernia, intussusception, intestinal obstruction, and ovarian torsion.
CT scanning provides very detailed images of many types of tissue as well as the lungs, bones, and blood vessels.CT scanning is painless, non invasive and accurate. CT has been shown to be a cost-effective imaging tool for a wide range of clinical problems. CT is less sensitive to patient movement than MRI.
The use of pediatric CT, which is a valuable imaging tool, has been increasing rapidly. However, because of the potential for increased radiation exposure to children undergoing these scans, pediatric CT is a public health concern CT can be a life saving tool for diagnosing illness and injury in children. For an individual child, the risks of CT are small and the individual risk-benefit balance favors the benefit when used appropriately.
Despite the many benefits of CT, a disadvantage is the inevitable radiation exposure.
Radiologists should continually think about reducing exposure as low as reasonably achievable by using exposure settings customized for children. (8,9) There has been revolutionary development in multidetector CT (MDCT) technology that has contributed to a substantial increase in its diagnostic applications and accuracy, even in children. However, a major drawback of MDCT is the use of ionizing radiation and, consequently, the risks of radiation-induced side effects.
It is generally believed that there is a linear-no threshold risk relationship. We should act as if low-dose radiation may well cause secondary cancer and reduce the medical radiation exposure to children as much as possible, the "as low as reasonably achievable" (ALARA) concept.
- Conditions
- Acute Abdomen in Children
- Being tested
- Multidetector Computerized Tomography (MDCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidetector Computerized Tomography (MDCT)Device
To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of ultrasound for diagnosis of acute abdominal pain in pediatric.
To evaluate the clinical examination and the role of ultrasound as a primary tool for diagnosis of non traumatic acute abdominal pain in pediatric.
Measured: Baseline
Secondary outcomes (1)
the multidetector CT.
Confirmation of the findings achieved by the primary tools by using the multidetector CT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Abdomen in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amal Fathy Abo Elgarad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amal Fathy Abo Elgarad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480983
- Sponsor's protocol ID
- MDCT in acute abdomen
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nievelstein RA, van Dam IM, van der Molen AJ. Multidetector CT in children: current concepts and dose reduction strategies. Pediatr Radiol. 2010 Aug;40(8):1324-44. doi: 10.1007/s00247-010-1714-7. Epub 2010 Jun 10.
PubMed 20535463
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multidetector Computerized Tomography (MDCT) in Diagnosis of Non Traumatic Acute Abdomen in Pediatric Age Group.
- ClinicalTrials.gov ID
- NCT04480983
- Acronym / sponsor ID
- MDCT in acute abdomen
- Conditions
- Acute Abdomen in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Amal Fathy Abo ElgaradUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 22 Jul 2020 (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.
To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
Detailed description
Acute abdominal pain is a common presenting symptom to the pediatric emergency department (1). The causes of the acute abdomen in pediatric patients are numerous, and diagnosis is often delayed due to misleading signs and symptoms.
Conditions that can be manifested by acute abdominal pain vary in incidence with age and sex. Classification of acute abdominal pain based on age is one adapted approach to narrow the differential diagnosis, which can guide selection of appropriate diagnostic tests, imaging, and definitive treatment.
While most of the emergency visits presenting with acute abdominal pain are self-limited and benign medical diagnoses, a surgical etiology may be present in up to 20%.(7) In nontraumatic cases of an acute abdomen below 1 year of age, the most common surgical etiology was reported to be incarcerated inguinal hernia (45.1%), followed by intussusception (41.9%). These etiologies were uncommon in school-age and adolescent children. In children above 1 year of age, the most common causes of acute surgical diagnoses have been reported to be acute appendicitis , incarcerated hernia, intussusception, intestinal obstruction, and ovarian torsion.
CT scanning provides very detailed images of many types of tissue as well as the lungs, bones, and blood vessels.CT scanning is painless, non invasive and accurate. CT has been shown to be a cost-effective imaging tool for a wide range of clinical problems. CT is less sensitive to patient movement than MRI.
The use of pediatric CT, which is a valuable imaging tool, has been increasing rapidly. However, because of the potential for increased radiation exposure to children undergoing these scans, pediatric CT is a public health concern CT can be a life saving tool for diagnosing illness and injury in children. For an individual child, the risks of CT are small and the individual risk-benefit balance favors the benefit when used appropriately.
Despite the many benefits of CT, a disadvantage is the inevitable radiation exposure.
Radiologists should continually think about reducing exposure as low as reasonably achievable by using exposure settings customized for children. (8,9) There has been revolutionary development in multidetector CT (MDCT) technology that has contributed to a substantial increase in its diagnostic applications and accuracy, even in children. However, a major drawback of MDCT is the use of ionizing radiation and, consequently, the risks of radiation-induced side effects.
It is generally believed that there is a linear-no threshold risk relationship. We should act as if low-dose radiation may well cause secondary cancer and reduce the medical radiation exposure to children as much as possible, the "as low as reasonably achievable" (ALARA) concept.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- The role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
Key inclusion criteria (1 listed)
- Patients presented by acute abdominal pain from first day of life till fifteen years old.
Key exclusion criteria (2 listed)
- Patients above 15 years old.
- Patients with traumatic cause of acute abdominal pain.
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 |
|---|---|---|
| Multidetector Computerized Tomography (MDCT)To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation. | Device | – |
Primary outcome
the role of ultrasound for diagnosis of acute abdominal pain in pediatric.
Time frame: Baseline
To evaluate the clinical examination and the role of ultrasound as a primary tool for diagnosis of non traumatic acute abdominal pain in pediatric.
1 secondary outcome
the multidetector CT.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Results publication: PubMed 20535463Nievelstein RA, van Dam IM, van der Molen AJ. Multidetector CT in children: current concepts and dose reduction strategies. Pediatr Radiol. 2010 Aug;40(8):1324-44. doi: 10.1007/s00247-010-1714-7. Epub 2010 Jun 10.
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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 Acute Abdomen in Children, run by Amal Fathy Abo Elgarad.
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 22 Jul 2020. 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 Amal Fathy (002/1069363096, amalfathy1406@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the role of ultrasound for diagnosis of acute abdominal pain in pediatric. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480983, which also lists 1 linked publication.
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 22 Jul 2020.