Overview

Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ramon R. Gorter
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Flevoziekenhuis
Red Cross Hospital Beverwijk
St. Antonius Hospital
Treatments:
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Criteria
Inclusion Criteria:

1. Age 7-17 years

2. Radiologically confirmed simple appendicitis, defined as:

a. Clinical findings: i. Unwell, but not generally ill ii. Localized tenderness in the
right iliac fossa region iii. Normal/hyperactive bowel sounds iv. No guarding v. No
mass palpable b. Ultrasonography: i. Incompressible appendix with an outer diameter of
≥6 mm ii. Hyperaemia within the appendiceal wall iii. Without fecalith iv.
Infiltration of surrounding fat v. No signs of perforation vi. No signs of intra
abdominal abscess/phlegmon

Exclusion criteria:

1. Patients with severe general illness at time of presentation:

1. Generalized peritonitis defined as:

Diffuse inflammation of the peritoneum with clinical signs consisting of
increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity,
sinus tachycardia, signs of paralytic ileus

2. Severe sepsis or septic shock, as defined by the international paediatric sepsis
consensus conference [39]. See attachment 1.

3. Signs of complex appendicitis

2. Children with a fecalith on ultrasonography.

3. Patients with serious associated conditions or malformations such as:

1. Congenital or acquired cardiac or pulmonary disease with significant hemodynamic
consequences

2. Immunodeficiency

3. Malignancy

4. Homozygous sickle cell disease

5. Metabolic disorders

4. Patient with documented type 1 allergy to the antibiotics used