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Study for a Rational Management of Appendicitis in Children (ALGAP)

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01067937
First received: February 11, 2010
Last updated: February 6, 2013
Last verified: February 2013

February 11, 2010
February 6, 2013
February 2009
April 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01067937 on ClinicalTrials.gov Archive Site
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Study for a Rational Management of Appendicitis in Children
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.

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Interventional
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Masking: Open Label
Appendicitis
Procedure: appendectomy
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
891
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, …)
Both
4 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01067937
BRD 08/6-L
Not Provided
General Director, Nantes University Hospital, Nantes University Hospital
Nantes University Hospital
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Nantes University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP