Study for a Rational Management of Appendicitis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

891 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Appendicitis

Study Design

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Blinding Strategy

NONE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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, …)

Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No