Antibiotic treatment alone for acute simple appendicitis in childre

Phase 1

Conditions: Radiologically confirmed simple appendicitis, defined as:a.Clinical findings:Unwell, but not generally ill, Localized tenderness in the right iliac fossa region, Normal/hyperactive bowel sounds, No guarding, No mass palpableb.Ultrasonography:Incompressible appendix with an outer diameter of =6 mm, hyperaemia within the appendiceal wall, with or without faecolith, infiltration of surrounding fat, no signs of perforation, no signs of intra abdominal abscess/phlegmone
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-004495-12-NL

Lead Sponsor: VU University Medical center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

•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

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

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 a faecolith on ultrasonography