CONTRACT
Research type
Research Study
Full title
CONservative Treatment of Appendicitis in Children – a randomised controlled Trial (Feasibility)
IRAS ID
214948
Contact name
Nigel Hall
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
ISRCTN Number
ISRCTN15830435
Duration of Study in the UK
2 years, 3 months, 31 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. Whilst there is growing interest in the use of non-operative treatment with antibiotics, we do not yet know whether this approach is safe and effective.
As there is a lack of evidence to inform surgeons, patients and parents whether non-operative treatment of acute uncomplicated appendicitis in children is effective, and cost effective; we intend to perform a multicentre prospective randomised controlled trial (RCT). Before this, a feasibility study is necessary to determine whether recruitment to a large RCT is possible and what is the best way to do the trial.
This feasibility study aims to recruit children aged 4 to 15 with a diagnosis of acute uncomplicated appendicitis. Recruitment will be over a period of 12 months and patients will be randomised to one of two arms. Standard Care Appendicectomy or the Non-operative Treatment Pathway (antibiotics and active observation). Patients will be recruited from 3 Children's hospitals and followed up for 6 months after discharge. The study is funded by the NIHR HTA programme
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0596
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion