Introduction

Antibiotic treatment for early acute appendicitis in children, is considered safe and effective

Aim

To investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and further, to investigate the safety of initial antibiotic treatment alone in terms of failures and complications of antibiotic treatment

Patient Profile

• 25 patients (aged 7–17 years) with simple appendicitis

Method

Study Design

• Multicenter, prospective cohort pilot study
• Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48–72 hours
• In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days and in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed
• Follow-up continued until 8 weeks after discharge

Endpoints

• Primary endpoint for feasibility: proportion of eligible patients willing to participate
• Safety endpoint: proportion of patients in whom antibiotic treatment failed (required appendectomy owing to lack of response) and the occurrence of major complications of antibiotic treatment
• Safety outcomes patients who underwent appendectomy: negative appendectomy, abscess formation, wound infection, wound rupture, wound herniation, readmission, reoperation, anesthesia-related complications, prolonged ileus requiring total parenteral nutrition, secondary bowel obstruction, and pneumonia

Results

Efficacy

• The primary endpoint for feasibility was achieved with an inclusion rate of 57% (25 patients participated)
• During the clinical phase of the study, all patients responded well to intravenous (IV) antibiotics, fulfilled the criteria for improvement after 72 hours and were discharged with oral antibiotics
• The initial antibiotic strategy (with an appendectomy in case of failure) was effective in all cases

Safety 

• Almost all patients on initial antibiotic treatment did not need appendectomy within 8 weeks after initial antibiotic treatment
• Delayed appendectomy was performed in two patients; both underwent laparoscopic appendectomy without complications
• The remaining 92% patients (n=23) were without symptoms at the 8 weeks follow-up
• Minor complications occurred in three patients; they recovered uneventfully after their complication
• None of the patients suffered from an adverse event or a recurrent appendicitis

Conclusion

An RCT comparing initial antibiotic treatment strategy with urgent appendectomy was feasible and safe in children with simple appendicitis

Surgery 2015; 157: 916-23