AppendicitisNCT04885335
Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study
An observational study of Appendicitis, run by University Hospital, Limoges at 1 site in France.
Trial summary
Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France. It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- PAS (Pediatric Appendicitis Score) survey
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 Jun 2022
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: -Child <16 years with abdominal symptoms and consulting in the pediatric emergency department of Limoges University center.
Who may be able to join
- Child <16 years
- abdominal symptoms
- consulting in the pediatric emergency department of Limoges University center.
Who cannot join
- Child >=16 years
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric emergency department
Limoges, 87000
Quentin Ballouhey, MD, quentin.ballouhey@unilim.fr
About this study
Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.
It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.
Read more
10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.
In 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.
The purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.
Furthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.
Appendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.
Most of the patients suffering from abdominal pain first consult their general practitioner.
- Conditions
- Appendicitis
- Being tested
- PAS (Pediatric Appendicitis Score) survey
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS (Pediatric Appendicitis Score) surveyOther
Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. core ≥ 7: very probable appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
PAS score
Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. Score ≥ 7: very probable appendicitis
Measured: At 5 month
Secondary outcomes (1)
Surgery for appendicitis
Measured: At 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jun 2022 (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 AppendicitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885335
- Sponsor's protocol ID
- BAlouhhey_appendicites
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vevaud K, Dallocchio A, Dumoitier N, Laspougeas A, Labrunie A, Belgacem A, Fourcade L, Ballouhey Q. A prospective study to evaluate the contribution of the pediatric appendicitis score in the decision process. BMC Pediatr. 2024 Feb 19;24(1):131. doi: 10.1186/s12887-024-04619-z.
PubMed 38373918
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study
- ClinicalTrials.gov ID
- NCT04885335
- Acronym / sponsor ID
- BAlouhhey_appendicites
- Conditions
- Appendicitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 13 May 2021 (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 appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.
It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.
10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.
In 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.
The purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.
Furthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.
Appendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.
Most of the patients suffering from abdominal pain first consult their general practitioner.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- -Child <16 years with abdominal symptoms and consulting in the pediatric emergency department of Limoges University center.
Key inclusion criteria (3 listed)
- Child <16 years
- abdominal symptoms
- consulting in the pediatric emergency department of Limoges University center.
Key exclusion criteria (1 listed)
- Child >=16 years
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 |
|---|---|---|
| PAS (Pediatric Appendicitis Score) surveyScore ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. core ≥ 7: very probable appendicitis | Other | – |
Primary outcome
PAS score
Time frame: At 5 month
Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. Score ≥ 7: very probable appendicitis
1 secondary outcome
Surgery for appendicitis
Time frame: At 5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Derived from this study: PubMed 38373918Vevaud K, Dallocchio A, Dumoitier N, Laspougeas A, Labrunie A, Belgacem A, Fourcade L, Ballouhey Q. A prospective study to evaluate the contribution of the pediatric appendicitis score in the decision process. BMC Pediatr. 2024 Feb 19;24(1):131. doi: 10.1186/s12887-024-04619-z.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by University Hospital, Limoges at 1 site in France.
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 3 inclusion and 1 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Quentin Ballouhey, MD (0555049027, quentin.ballouhey@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAS score (time frame: At 5 month). 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 NCT04885335, 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 13 May 2021.