Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children (APAC)
Appendicitis
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, Appendectomy, Antibiotics
Eligibility Criteria
Inclusion Criteria:
- Age 7-17 years
Radiologically confirmed simple appendicitis, defined as:
Clinical findings:
- Unwell, but not generally ill
- Localized tenderness in the right iliac fossa region
- Normal/hyperactive bowel sounds
- No guarding
- No mass palpable
Ultrasonography:
- Incompressible appendix with an outer diameter of ≥6 mm
- Hyperaemia within the appendiceal wall
- Without faecolith
- Infiltration of surrounding fat
- No signs of perforation
- No signs of intra-abdominal abscess/phlegmon
Exclusion Criteria:
- Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system).
Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:
- Diffuse abdominal guarding (3 points)
- C-Reactive Protein level more than 38 mg/L (2 points)
- Signs on ultrasound indicative of complex appendicitis (2 points)
- More than one day abdominal pain (2 points)
- Temperature: more than 37.5 degree Celsius (1 point)
- Faecolith (ultrasound)
- Serious co-morbidity
- Recurrent appendicitis
- Suspicion of an underlying malignancy or inflammatory bowel disease
- Documented type 1 allergy to the antibiotics used.
Sites / Locations
- Medical Center Alkmaar
- Flevoziekenhuis
- Amstelland
- AMC
- OLVG
- VU University medical center
- Gelre Hospital
- Rijnstate
- Red Cross Hospital
- Haga ziekenhuis
- Albert Schweitzer
- Maxima medical center
- Zuyderland
- Antonius Hospital
- Franciscus, Gasthuis en Vlietland
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Augmentin + Gentamicin
Operative treatment strategy
Initial non-operative treatment strategy reserving an appendectomy for those not responding or with recurrent disease. It consist of: Clinical observation for 48 hours with administration of 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 for 48 hours. If after 48 hours the patient fulfils the predefined discharge criteria, the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days and discharge. An appendectomy is reserved for those patients with clinical deterioration, non-improvement after 72 hours or recurrent appendicitis. Pain medication according to national protocol.
Clinical observation and semi-urgent appendectomy. Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics. Discharge if the patient fulfils the predefined discharge criteria. Pain medication according to national protocol.