Non-operative treatment of children with appendicitis vs appendectomy

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Children aged 4-15 years who have acute appendicitis

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with the current standard treatment which involves an operation to remove the appendix. Those in the second group are treated with antibiotics both through a drip and by mouth. Children in both groups are monitored closely during their time in hospital to make sure they are getting better. Once the doctors are happy with the patient’s recovery and they are able to take fluid, food and painkillers by mouth, as well as move around, they are discharged home with any necessary information about appendicitis and their recovery. All patients attend three follow-up appointments to ensure that they are healthy and not experiencing any issues. These appointments will take place 6 weeks and 4, 8 and 12 months after they are discharged from hosptial. At these visits and during the stay in hospital, parents are asked to fill in a questionnaire about their child’s health status.

What are the possible benefits and risks of participating?
Participants who undergo surgery benefit from an improvement to their condition, as surgical removal of the appendix is the best-known treatment for acute appendicitis. Having an operation will require general anaesthesia and involves a small number of risks related to surgery including bleeding, wound infection, a collection of pus in the abdomen, and in rare cases bowel obstruction requiring further surgery. There is also a 10% chance that the operation may show a healthy appendix, which means that the surgery was not necessary. In this case the appendix is removed anyway.
Participants treated with antibiotics benefit from avoiding surgery and the risks that it entails. If a child is treated with antibiotics, there is a small risk that the antibiotic treatment may not work. However, data collected on children with acute uncomplicated appendicitis who have been treated with antibiotics, suggest that it works in the majority of cases (97%). Children will be monitored closely whilst they are in hospital and if there is no improvement with antibiotic treatment, they will have an operation to remove the appendix. The other risk of antibiotic treatment is that the child will still have their appendix and may get appendicitis again. If this were to happen then they would have their appendix removed.

Where is the study run from?
Southampton Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
January 2021 to September 2027

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Miss Jessica Kelly (public)
contract@soton.ac.uk
2. Mr Nigel Hall (scientific)
n.j.hall@soton.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University Hospital Southampton NHS Foundation Trust
Hospital/treatment centre

R&D Dept, E Level, L123
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Phone	+44 (0)23 8120 5146
Email	sponsor@uhs.nhs.uk
Website	http://www.uhs.nhs.uk/home.aspx
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

18/08/2024: Study participating centre James Paget University Hospital was added.
28/02/2024: The recruitment end date was changed from 28/02/2026 to 31/12/2025.
21/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/02/2024 to 28/02/2026.
2. The overall end date was changed from 01/09/2025 to 01/09/2027.
3. The intention to publish date was changed from 01/09/2026 to 01/09/2028.
4. The plain English summary was updated to reflect these changes.
01/11/2023: The following changes were made:
1. The Royal Alexandra Children's Hospital and the Oxford Radcliffe Hospital NHS Trust were added as study participating centres.
2. The recruitment end date was changed from 30/11/2023 to 29/02/2024.
3. Cambridge University Hospital and Edinburgh were removed as study participating centres.
23/03/2023: IPD sharing statement added.
10/02/2023: Trial website added.
20/12/2022: The following changes were made to the trial record:
1. A contact was changed.
2. The trial participating centres Royal London Hospital, Gartnavel Royal Hospital, Nottingham University Hopsital were removed and The Royal Belfast Hospital for Sick Children, Birmingham Children's Hospital, Royal Hospital for Sick Children (Glasgow) were added.
29/12/2021: The following changes have been made:
1. The ethics approval information has been added.
2. The recruitment start date has been changed from 01/12/2021 to 31/01/2022.
3. The publication and dissemination plan has been updated.
28/07/2021: Trial's existence confirmed by the NIHR.