Skip to content

Antibiotica voor de behandeling van acute blindedarmontsteking bij kinderen.

Antibiotic treatment alone for acute simple appendicitis in children; a pilot study part of the APAC trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26391
Enrollment
50
Registered
2011-03-15
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis children Antibiotic treatment Non-operative treatment

Interventions

Initial antibiotic treatment strategy (IATS): Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily
maximum 6000/600mg a day) and gentamicin 7mg/kg once daily will be given for 48 hours. If possible the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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 (see appendix 13.13): i. Incompressible appendix with an outer diameter of ≥6 mm ii. Hyperaemia within the appendiceal wall iii. Without faecolith iv. Infiltration of surrounding fat v. No signs of perforation vi. No signs of intra-abdominal abscess/phlegmone

Exclusion criteria

Exclusion criteria: 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 [38]. (appendix 13.6) c. Signs of complex appendicitis 2. Children with a faecolith on ultrasonography. 3. 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

Design outcomes

Primary

MeasureTime frame
Safety of initial antibiotic treatment defined as: Occurrence of major complications, such as: A. Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy

Secondary

MeasureTime frame
Major complications associated with appendectomy a. Stumpleakage b. Intra-abdominal abscess (IAA) c. Secondary bowel obstruction (SBO) d. Superficial site infection (SSI) e. Need for secondary operation f. Need for other re-intervention g. Re-admission h. Anaesthesia related complication i. Pneumonia

Contacts

Public ContactR.R. Gorter

Kinderchirurgisch Centrum Amsterdam, Emma's Kinderziekenhuis AMC & VU medisch centrum

rr.gorter@vumc.nl+31 (0)20 4444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)