NCT01067937

Study for a Rational Management of Appendicitis in Children

Multicenter Prospective Study for a Rational Management of Appendicitis in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 891 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-02-12
• Last updated: 2013-02-07

Locations

8 sites across 1 country: France