Appendicitis AcuteNCT03171662
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score
A study testing Evaluation of Pediatric Appendicitis Score in people with Appendicitis Acute, run by Assiut University.
Trial summary
Appendicitis is the most common abdominal disease requiring surgery in children. The risk of developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls. Despite its high incidence, there are still diagnostic difficulties. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Evaluation of Pediatric Appendicitis Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Dec 2019
- Phase
- Interventional
- 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 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (1-15 years old) coming to hospital with abdominal pain and diagnosed provisionally as acute appendicitis .
Who cannot join
- Children below 1 year old or above 15 years old.
- Complicated appendicitis ( mass or abcess ).
- Patient with recent history of any abdominal surgeries.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score ( PAS ) as a Diagnostic Tool for Acute Appendicitis in Children
Appendicitis is the most common abdominal disease requiring surgery in children. The risk of developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls. Despite its high incidence, there are still diagnostic difficulties. The overall negative appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute appendicitis is considered to be especially challenging in children due to difficulties in communication and examination.
Read the detailed description
The diagnostic difficulties result in increased risks of both negative appendectomies and a delayed diagnosis, both leading to increased morbidity, more complications, longer hospital stay, and higher costs. These risks are further increased in the younger children. The doctor delay is a known cause contributing to late diagnosis in young children. Other studies, with patients under 3 years and 4 years of age, have found parent delay to contribute as well to the late diagnosis. Our clinical experience, confirmed by the literature, shows that the younger children with acute appendicitis deviate from the typical presentation and clinical findings observed in older children with acute appendicitis.
The use of a clinical score, based on patient history and examination, is one way to possibly improve the diagnostic procedure. There are several available scores. In this systematic review, Pediatric Appendicitis Score (PAS) were considered the most reliable. Pediatric Appendicitis Score is the only score specifically developed for children, composed by Samuel in 2002 when analyzing children between 4 and 15 years of age. Pediatric Appendicitis Score has been validated and recommended by some authors, but only one of these studies has included children less than 4 years of age.
We hypothesized that PAS could be helpful in diagnosing young children with appendicitis and that we would find both parent delay and doctor delay contributing to the often late diagnosis in this age group. The aims of this study were to (1) evaluate Pediatric Appendicitis Score in children, operated on for suspected appendicitis, with respect to Pediatric Appendicitis Score sensitivity, specificity, positive predictive value, and negative predictive value; (2) investigate if there was a delay in diagnosing appendicitis; and (3) identify factors responsible for the possible late diagnosis in younger children In order to improve the diagnostic accuracy of acute appendicitis, ultrasound, computed tomography and post-appendectomy histopathological examination have been used as clinical aids in cutting down the rate of negative appendectomy without increasing morbidity and mortality.
- Conditions
- Appendicitis Acute
- Being tested
- Evaluation of Pediatric Appendicitis Score
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Pediatric Appendicitis ScoreOther
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
| Study group | Role | What they receive |
|---|---|---|
| group study | Experimental | Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score Receives: Other: Evaluation of Pediatric Appendicitis Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric appendicitis score
post-appendectomy histopathology
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Samir Rateeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171662
- Sponsor's protocol ID
- PASE
- Status last verified
- May 2017
- First submitted
- 27 May 2017
- Last updated
- 6 Jun 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 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score ( PAS ) as a Diagnostic Tool for Acute Appendicitis in Children
- ClinicalTrials.gov ID
- NCT03171662
- Acronym / sponsor ID
- PASE
- Conditions
- Appendicitis Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 31 May 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.
Appendicitis is the most common abdominal disease requiring surgery in children. The risk of developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls. Despite its high incidence, there are still diagnostic difficulties. The overall negative appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute appendicitis is considered to be especially challenging in children due to difficulties in communication and examination.
Detailed description
The diagnostic difficulties result in increased risks of both negative appendectomies and a delayed diagnosis, both leading to increased morbidity, more complications, longer hospital stay, and higher costs. These risks are further increased in the younger children. The doctor delay is a known cause contributing to late diagnosis in young children. Other studies, with patients under 3 years and 4 years of age, have found parent delay to contribute as well to the late diagnosis. Our clinical experience, confirmed by the literature, shows that the younger children with acute appendicitis deviate from the typical presentation and clinical findings observed in older children with acute appendicitis.
The use of a clinical score, based on patient history and examination, is one way to possibly improve the diagnostic procedure. There are several available scores. In this systematic review, Pediatric Appendicitis Score (PAS) were considered the most reliable. Pediatric Appendicitis Score is the only score specifically developed for children, composed by Samuel in 2002 when analyzing children between 4 and 15 years of age. Pediatric Appendicitis Score has been validated and recommended by some authors, but only one of these studies has included children less than 4 years of age.
We hypothesized that PAS could be helpful in diagnosing young children with appendicitis and that we would find both parent delay and doctor delay contributing to the often late diagnosis in this age group. The aims of this study were to (1) evaluate Pediatric Appendicitis Score in children, operated on for suspected appendicitis, with respect to Pediatric Appendicitis Score sensitivity, specificity, positive predictive value, and negative predictive value; (2) investigate if there was a delay in diagnosing appendicitis; and (3) identify factors responsible for the possible late diagnosis in younger children In order to improve the diagnostic accuracy of acute appendicitis, ultrasound, computed tomography and post-appendectomy histopathological examination have been used as clinical aids in cutting down the rate of negative appendectomy without increasing morbidity and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group study | Experimental | Other: Evaluation of Pediatric Appendicitis ScoreImaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (1-15 years old) coming to hospital with abdominal pain and diagnosed provisionally as acute appendicitis .
Key exclusion criteria (3 listed)
- Children below 1 year old or above 15 years old.
- Complicated appendicitis ( mass or abcess ).
- Patient with recent history of any abdominal surgeries.
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 |
|---|---|---|
| Evaluation of Pediatric Appendicitis ScoreImaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score | Other | group study |
Primary outcome
pediatric appendicitis score
Time frame: 2 days
post-appendectomy histopathology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
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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?
A study testing Evaluation of Pediatric Appendicitis Score in people with Appendicitis Acute, 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 3 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 6 Jun 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 Mahmoud Mostafa, MD (00201005010897, Profmmmostafa53@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric appendicitis score (time frame: 2 days). 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 6 Jun 2017.