Study for a Rational Management of Appendicitis in Children

Appendicitis Clinical Trial

— ALGAP  

Official title:

Multicenter Prospective Study for a Rational Management of Appendicitis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067937
• Other study ID #: BRD 08/6-L
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: February 6, 2013
• Start date: February 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Masking: Open Label

Related Conditions & MeSH terms

• Appendicitis

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,