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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01067937
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : February 7, 2013
Information provided by:
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Appendicitis Procedure: appendectomy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Masking: None (Open Label)
Official Title: Multicenter Prospective Study for a Rational Management of Appendicitis in Children
Study Start Date : February 2009
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Intervention Details:
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, …)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067937

WEIL Dominique
Angers, France, 49000
DE VRIES Philine
Brest, France, 29200
PETIT Thierry
Caen, France, 14033
PODEVIN Guillaume
Nantes, France, 44093
Poitiers, France, 86021
AZZIS Olivier
Rennes, France, 35033
Saint-Brieuc, France, 22027
LARDY Hubert
Tours, France, 37044
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: General Director, Nantes University Hospital, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01067937     History of Changes
Other Study ID Numbers: BRD 08/6-L
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Nantes University Hospital:

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases