CONTRACT 2
Research type
Research Study
Full title
CONservative TReatment of Appendicitis in Children – a randomised controlled Trial – CONTRACT 2
IRAS ID
302249
Contact name
Nigel Hall
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
ISRCTN Number
ISRCTN16720026
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Acute appendicitis is the most common surgical emergency in children. The lifetime risk of getting appendicitis is 7-8% and the most common age for appendicitis is in the early teens. Appendicectomy is considered the gold standard treatment for acute appendicitis by most surgeons and involves an operation to remove the appendix. Although appendicectomy is usually a simple procedure, it requires a general anaesthetic and there are other risks associated with surgery.
Many parents find the idea that their child needs emergency surgery frightening and one they are keen to avoid if an alternative is available. An alternative approach to the treatment of children with acute appendicitis would be with antibiotics and no appendicectomy. Work we have undertaken with parents shows that over 80% would be willing to consider nonoperative treatment for their child with appendicitis and 60% would prefer non-operative treatment to surgery if outcomes were similar (20% preferred surgery and 20% expressed no-preference).
An alternative would be to treat children non-operatively, without surgery but with antibiotics. This would have the benefit of avoiding an operation and potential side effects but would only be acceptable if antibiotic treatment has a high success rate and the risk of serious complications and recurrent appendicitis is low. Although research to date has confirmed that most children with uncomplicated acute appendicitis can be successfully treated without surgery, there have been no randomised controlled trials (RCTs) reported that directly compare these two very different treatments. This RCT will randomise between Standard Care Appendicectomy or the Non-operative Treatment Pathway (antibiotics and active observation). Patients will be recruited from up to 15 Children's hospitals and followed up for 12 months after randomisation. The study is funded by the NIHR HTA programme.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0317
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion