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Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a
Nigel J Hall1, Simon Eaton2, Olivier Abbo3
1University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, Hampshire, UK.
Insights
This study compares antibiotic treatment versus appendectomy for acute appendicitis in children. It aims to determine if non-operative care is a safe and effective alternative to surgery for pediatric appendicitis.
Area of Science:
- Pediatric Surgery
- Gastroenterology
- Clinical Trials
Background:
- Appendectomy is the standard treatment for acute appendicitis.
- There's increasing interest in non-operative antibiotic treatment for pediatric appendicitis.
- Previous studies lacked the power to compare these treatments effectively.
Purpose of the Study:
- To compare the efficacy of non-operative antibiotic treatment with appendectomy for acute uncomplicated appendicitis in children.
- To evaluate treatment failure rates within one year of randomization.
- To conduct a cost-effectiveness analysis of both treatment approaches.
Main Methods:
- A multicenter, international, randomized controlled trial with a non-inferiority design.
- Children aged 5-16 with acute uncomplicated appendicitis were randomized (1:1) to either laparoscopic appendectomy or antibiotic treatment (IV followed by oral).
- The primary outcome was treatment failure, defined as additional intervention or negative appendectomy within one year. Planned sample size is 978 children.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The APPY trial is the first multicenter randomized trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children.
- Results have the potential to significantly alter the management of this common condition.
- The randomized design minimizes bias in outcome assessment.
Background:
Appendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.
Methods:
Multicentre, international, randomised controlled trial with a non-inferiority design. Children (age 5-16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.
Discussion:
The APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.
Trial Registration Number:
clinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.
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