CONTRACT 2

Title

CONservative TReatment of Appendicitis in Children – a randomised controlled Trial – CONTRACT 2

Description

Acute appendicitis is a sudden, painful swelling of the appendix, and is the most common surgical emergency in children. People have around a 7-8% chance of developing appendicitis at some point in their lives and the most common age for appendicitis is in the early teens. An 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 the use of a general anaesthetic (medication to put patients to sleep during surgery) 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 treatment with antibiotics. Whilst there is growing interest in the use of non-operative treatment with antibiotics, it is not yet known whether this approach is safe and effective. The aim of this study is to look at the effectiveness and cost-effectiveness of non-operative treatment of acute appendicitis with antibiotics.

Objectives

Primary:

• To determine whether non-operative treatment is non-inferior to appendicectomy for the treatment of children with uncomplicated acute appendicitis. The primary outcome of ‘treatment success’ will be assessed at 1 year following randomisation.

Secondary:

• To compare non-operative treatment with appendicectomy in terms of other important patient and family centred outcomes and cost. Outcomes will include duration of hospital stay, measures of recovery from acute appendicitis, complications, need for further treatment, persistent symptoms, health care resource use, quality of life and costs. We will measure all applicable outcomes in our recently developed core outcome set.

Trial Design

A multicentre, open label randomised non-inferiority controlled trial with internal pilot and health economic evaluation comparing a non-operative treatment pathway with appendicectomy. Both groups of children will receive broad spectrum antibiotics from the point of enrolment; one group of children will undergo urgent appendicectomy, the other will be treated non-operatively with continuation of broad spectrum intravenous antibiotics. Patients enrolled in the study will be randomised at a ratio of 1:1.

Trial Status

Open to recruitment

Population:

Children (aged 4-15 years) with a clinical diagnosis of acute uncomplicated appendicitis.

This trial is funded by a National Institute for Health and care Research Health Technology Assessment (HTA) grant (award reference no. NIHR131346)