Study for a Rational Management of Appendicitis in Children (ALGAP)
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Purpose
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 | Intervention |
|---|---|
|
Appendicitis |
Procedure: appendectomy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label |
| Official Title: | Multicenter Prospective Study for a Rational Management of Appendicitis in Children |
| Enrollment: | 891 |
| Study Start Date: | February 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
-
Procedure: appendectomy
Eligibility| Ages Eligible for Study: | 4 Years to 15 Years |
| Genders Eligible for Study: | Both |
| 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, …)
Contacts and Locations| France | |
| WEIL Dominique | |
| Angers, France, 49000 | |
| DE VRIES Philine | |
| Brest, France, 29200 | |
| PETIT Thierry | |
| Caen, France, 14033 | |
| PODEVIN Guillaume | |
| Nantes, France, 44093 | |
| MCHEIK Jiad | |
| Poitiers, France, 86021 | |
| AZZIS Olivier | |
| Rennes, France, 35033 | |
| GARIGNON Cynthia | |
| Saint-Brieuc, France, 22027 | |
| LARDY Hubert | |
| Tours, France, 37044 | |
More Information
No publications provided
| 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 |
| Study First Received: | February 11, 2010 |
| Last Updated: | February 6, 2013 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Nantes University Hospital:
|
Appendicitis children |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013