Study for a Rational Management of Appendicitis in Children (ALGAP)

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01067937
First received: February 11, 2010
Last updated: February 6, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067937

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
Sponsors and Collaborators
Nantes University Hospital
  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 July 28, 2014