CONservative TReatment of Appendicitis in Children – a randomised controlled Trial – CONTRACT 2
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.
Primary:
Secondary:
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.
Open to recruitment
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)
Senior Trial Manager
Liz Dixon
Trial Manager
Jessica Kelly
Data Manager
Robert Waugh
Clinical Data Coordinator
Sophie McKenna
Email: contract@soton.ac.uk
Phone: 023 8120 4128
Email: ctu@soton.ac.uk
Protocol
CONTRACT 2 - Protocol v6, 05-Apr-2023
Patient information Sheets
CONTRACT 2 - Parent Info Sheet v4, 12-Jan-2023
CONTRACT 2 - Teenagers Info Sheet V2 10-Nov-21
CONTRACT 2 - Young Person Info Sheet V1 11-Aug-21
Consent/Assent forms
CONTRACT 2 - Consent form v5, 16-Jan-2023
CONTRACT 2 - Child Assent Form v1 10-Nov-21
Communication Sub-Study
CONTRACT 2 - Coms Substudy HP consent form v3, 19-Jan-2023
CONTRACT 2 - Coms Substudy HP PIS v4, 19-Jan-2023
CONTRACT 2 - Coms Substudy Parent Consent form v1, 12-Jan-2023
Parent/Caregiver guide for eCOA App
CONTRACT 2 - eCOA App Patient Quick Reference Guide_v.3.0
Other Essential Documents
CONTRACT 2 - GP Letter V1 19-Aug-21
CONTRACT 2 - Site Delegation Log v5 05-Mar-21_CONTRACT 2 V1 13-10-21
CONTRACT 2 - Screening Log V5 18-Jul-2022
CONTRACT 2 - Site Training Log Template v1 06-Jun-2019 CONTRACT 2 V1 13-OCT-21
CONTRACT 2 - Patient Diary Card v8, 27-Jan-2023
CONTRACT 2 - Poster v2, 30-Jan-2023
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