Study for a Rational Management of Appendicitis in Children

Not Applicable

Completed

• Conditions: Appendicitis

• Registration Number: NCT01067937
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 891

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, ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

WEIL Dominique; 🇫🇷 Angers, France

DE VRIES Philine; 🇫🇷 Brest, France

PETIT Thierry; 🇫🇷 Caen, France

PODEVIN Guillaume; 🇫🇷 Nantes, France

MCHEIK Jiad; 🇫🇷 Poitiers, France

AZZIS Olivier; 🇫🇷 Rennes, France

GARIGNON Cynthia; 🇫🇷 Saint-Brieuc, France

LARDY Hubert; 🇫🇷 Tours, France