AppendicitisALGAPNCT01067937
Study for a Rational Management of Appendicitis in Children
A study testing appendectomy in people with Appendicitis, run by Nantes University Hospital at 8 sites in France.
Trial summary
Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 891 participants
- Where
- 8 sitesFrance
- Study dates
- Feb 2009to Apr 2011
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male and female children, between 4 and 15 years-old, with more than 37,5°C of body temperature during the 3 days before hospital admission, and with abdominal pain located in right or median lower quadrant
Who cannot join
- children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, …)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
WEIL Dominique
Angers, 49000
DE VRIES Philine
Brest, 29200
PETIT Thierry
Caen, 14033
PODEVIN Guillaume
Nantes, 44093
MCHEIK Jiad
Poitiers, 86021
AZZIS Olivier
Rennes, 35033
GARIGNON Cynthia
Saint-Brieuc, 22027
LARDY Hubert
Tours, 37044
About this study
Official title: Multicenter Prospective Study for a Rational Management of Appendicitis in Children
Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. Evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.An algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. The main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.
- Conditions
- Appendicitis
- Being tested
- appendectomy
- Keywords
- Appendicitis, children
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyProcedure or surgery
Randomisation will apply to the 8 participating centers as follow: During a first survey period of 6 month, the algorithm is not applied; The six following months, 4 randomised centers applied the algorithm, the others being still survey; The six last month, all centers will apply the algorithm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067937
- Sponsor's protocol ID
- BRD 08/6-L
- Acronym
- ALGAP
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study for a Rational Management of Appendicitis in Children
- ClinicalTrials.gov ID
- NCT01067937
- Acronym / sponsor ID
- ALGAP / BRD 08/6-L
- Conditions
- Appendicitis
- Keywords
- Appendicitis, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Feb 2010 (estimated)
- 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.
Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. Evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.An algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. The main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.
Study design
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- male and female children, between 4 and 15 years-old, with more than 37,5°C of body temperature during the 3 days before hospital admission, and with abdominal pain located in right or median lower quadrant
Key exclusion criteria (1 listed)
- children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, …)
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 |
|---|---|---|
| appendectomyRandomisation will apply to the 8 participating centers as follow: During a first survey period of 6 month, the algorithm is not applied; The six following months, 4 randomised centers applied the algorithm, the others being still survey; The six last month, all centers will apply the algorithm | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing appendectomy in people with Appendicitis, run by Nantes University Hospital at 8 sites 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 1 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: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 7 Feb 2013.