Non operative treatment of children with appendicitis vs appendectomy – A feasibility study
| ISRCTN | ISRCTN15830435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15830435 |
| Protocol serial number | 32463 |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 30/01/2017
- Registration date
- 08/02/2017
- Last edited
- 08/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 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 feasibility of recruiting participants to take part in a study looking at the effectiveness and cost-effectiveness of non-operative treatment of acute appendicitis with antibiotics, to see if conducting a full scale study would be possible.
Who can participate?
Children aged 4-15 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 six weeks, three months and six months after they are discharged from hosptial. At these visits and during the stay in hospital, parents are asked to fill in two short questionnaires about their child’s health status. Parents are also given the same questionnaires at discharge to fill in and return two weeks after they have gone home.
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?
1. Southampton Children’s Hospital (UK)
2. St George’s Hospital (UK)
3. Alder Hey Children’s Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2016 to October 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Miss Natalie Hutchings (public)
contract@soton.ac.uk
2. Mr Nigel Hall (scientific)
n.j.hall@soton.ac.uk
Contact information
Public
Southampton Clinical Trials Unit
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 23 8120 4128 |
|---|---|
| contract@soton.ac.uk |
Scientific
University Surgery Unit, MP 816
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0001-8570-9374 |
|---|---|
| Phone | +44 23 8077 7222 |
| n.j.hall@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Drug, Management of Care, Surgery, Active Monitoring |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The title given on the patient information sheet is: CONservative TReatment of Appendicitis in Children a randomised controlled Trial CONTRACT (Feasibility) |
| Study acronym | CONTRACT |
| Study objectives | The aim of this study is to assess the feasibility of recruiting participants in order to inform the feasibility of a large randomised controlled trial looking at whether non-operative treatment of acute uncomplicated appendicitis in children is effective, and cost effective. |
| Ethics approval(s) | South Central – Hampshire A Research Ethics Committee, 22/11/2016, ref: 16/SC/0596 |
| Health condition(s) or problem(s) studied | Specialty: Children, Primary sub-specialty: Gastroenterology, Hepatology and Nutrition; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of appendix |
| Intervention | Participants are randomised using an online randomisation system in a 1:1 ratio between the 2 treatment arms. Minimisation will be used for age, gender, duration of symptoms before randomisation and centre. Treatment Arm A: Non Operative Treatment Patients will be treated in hospital with a minimum of 24 hours intravenous antibiotics followed by oral antibiotics until the doctors feel they meet criteria for discharge. They will be monitored during their stay in hospital to ensure recovery and if at any stage they are deteriorating, or have not improved by 48 hours post randomisation, they will be referred for an appendicectomy. Time in hospital may vary for each patient but it is expected that the patient will be in hospital for a minimum of 48 hours. The follow up will be for 6 months from the date of first discharge from hospital. Treatment Arm B: Appendicectomy Patients will be treated with intravenous antibiotics until it is time for their operation. The operation will require a general anaesthetic to remove the appendix, either by laparoscopic or open surgery. Time in hospital may vary for each patient depending on their recovery rate. Standard care estimates the patient will be in hospital for a few days. Again, the follow up will be for 6 months from the date of first discharge from hospital. The follow up period involves 3 appointments at 6 weeks, 3 months and 6 months. All patients, or a member of their family, will be asked to complete 2 questionnaires at randomisation, discharge, 2 weeks, 6 weeks, 3 months and 6 months. Patients will also be asked to complete a diary card for the 2 weeks immediately after discharge and an extra questionnaire at the 6 weeks and 6 months follow up appointments. |
| Intervention type | Other |
| Primary outcome measure(s) |
Proportion of eligible patients recruited to the study over 12 months is measured by the number of patients who consent and are randomised into the study by 12 months divided by the total number of patients who were eligible and screened for the study by 12 months. |
| Key secondary outcome measure(s) |
1. Willingness of parents and children to be enrolled in, and surgeons to recruit to, a randomised study comparing operative versus non-operative treatment and identify anticipated recruitment rate - measured in parallel qualitative workstream through patient/parent interviews, surgeon surveys and focus groups |
| Completion date | 31/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 65 |
| Total final enrolment | 57 |
| Key inclusion criteria | 1. Child age 4 – 15 years (<16 years and >3 years) 2. Clinical diagnosis, either with or without radiological assessment, of acute appendicitis which prior to study commencement would be treated with appendicectomy 3. Written informed parental consent, with child assent if appropriate |
| Key exclusion criteria | 1. Clinical signs or radiological findings to suggest perforated appendicitis 2. Presentation with appendix mass 3. Previous episode of appendicitis or appendix mass treated non-operatively 4. Major anaesthetic risk precluding allocation to the appendicectomy arm 5. Known antibiotic allergy preventing allocation to non-operative treatment arm 6. Antibiotic treatment started at referring institution (defined as 2 or more doses administered) 7. Cystic fibrosis 8. Positive pregnancy test 9. Current treatment for malignancy |
| Date of first enrolment | 13/02/2017 |
| Date of final enrolment | 28/02/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
East Prescot Road
Liverpool
L14 5AB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/01/2021 | 18/01/2021 | Yes | No |
| Results article | 01/02/2023 | 07/02/2023 | Yes | No | |
| Protocol article | protocol | 02/03/2018 | 27/11/2020 | Yes | No |
| Protocol article | protocol | 01/02/2021 | 26/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | qualitative study | 30/03/2020 | 27/11/2020 | Yes | No |
| Other publications | 07/06/2023 | 08/06/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/06/2023: Publication reference added.
07/02/2023: Publication reference added.
26/02/2021: Publication reference added.
18/01/2021: Publication reference added.
27/11/2020: Publication references added.
22/10/2019: Total final enrolment number added.
21/03/2018: Recruitment end date was changed from 12/02/2018 to 28/02/2018.
