Study for a Rational Management of Appendicitis in Children
ALGAP
Multicenter Prospective Study for a Rational Management of Appendicitis in Children
1 other identifier
interventional
891
1 country
8
Brief 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 %. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 7, 2013
February 1, 2013
2.2 years
February 11, 2010
February 6, 2013
Conditions
Keywords
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, …)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
WEIL Dominique
Angers, 49000, France
DE VRIES Philine
Brest, 29200, France
PETIT Thierry
Caen, 14033, France
PODEVIN Guillaume
Nantes, 44093, France
MCHEIK Jiad
Poitiers, 86021, France
AZZIS Olivier
Rennes, 35033, France
GARIGNON Cynthia
Saint-Brieuc, 22027, France
LARDY Hubert
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
February 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
February 7, 2013
Record last verified: 2013-02