Antibiotic treatment alone for children with acute appendicitis; a prospective cohort study part of the Antibiotic versus Primary Appendectomy for Children with acute appendicitis; the APAC trial.
- Conditions
- Appendicitisinflamed appendix10017966
- Registration Number
- NL-OMON39690
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
* Written Informed consent obtained
* Age 7-17 years
* 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. With or without faecolith
iv. Infiltration of surrounding fat
v. No signs of perforation
vi. No signs of intra abdominal abscess/phlegmone
The following patients will be excluded from participating in this study:
1. Patients with severe general illness at time of presentation:
a. 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
b. Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [36]. See attachment 1.
c. Signs of complex appendicitis;2. Patients with serious associated conditions or malformations such as:
a. Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
b. Immunodeficiency
c. Malignancy
d. Homozygous sickle cell disease
e. Metabolic disorders;3. Patient with documented type 1 allergy to the antibiotics used;4. Children with faecolith on ultrasound
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Safety of antibiotic treatment defined as:<br /><br>Occurrence of major complications:<br /><br>a. Anaphylactic shock and other allergic reaction to antibiotics administered.<br /><br>b. Recurrent appendicitis within 8 weeks<br /><br>c. Recurrent appendicitis within one year after discharge<br /><br>d. Development of perforated appendicitis<br /><br>e. Occurrence of major complaints after delayed appendectomy such as<br /><br>Intra-abdominal abscess, stump leakage, secondary bowel obstruction,<br /><br>superficial site infection, need for secondary operation, need for<br /><br>re-intervention other than appendectomy, re-admission, anaesthesia related<br /><br>complications, pneumonia.<br /><br>f. Re-admission<br /><br>g. Re-intervention other than delayed appendectomy</p><br>
- Secondary Outcome Measures
Name Time Method