RT Journal Article
SR Electronic
T1 Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial
JF BMJ Paediatrics Open
FD BMJ Publishing Group Ltd
SP bmjpo-2017-000028
DO 10.1136/bmjpo-2017-000028
VO 1
IS 1
A1 Nigel J Hall
A1 Simon Eaton
A1 Olivier Abbo
A1 Alexis P Arnaud
A1 Marianne Beaudin
A1 Mary Brindle
A1 Andreana Bütter
A1 Dafydd Davies
A1 Tim Jancelewicz
A1 Kathy Johnson
A1 Richard Keijzer
A1 Eveline Lapidus-Krol
A1 Martin Offringa
A1 Nelson Piché
A1 Risto Rintala
A1 Erik Skarsgard
A1 Jan F Svensson
A1 Wendy J Ungar
A1 Tomas Wester
A1 Andrew R Willan
A1 Augusto Zani
A1 Shawn D St Peter
A1 Agostino Pierro
YR 2017
UL http://bmjpaedsopen.bmj.com/content/1/1/bmjpo-2017-000028.abstract
AB 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.