Plain English Summary
Background and study aims
A proportion of children with acute appendicitis develop a swelling around the appendix called an appendix mass. From experience, we know that removing the appendix in such children is likely to result in complications so these children are usually treated with intravenous antibiotics rather than with an operation to remove the appendix. Once the child has recovered, most surgeons recommend an operation (called interval appendicectomy) to remove the appendix several months later to prevent the child from getting appendicitis again. It is not known whether this operation is actually necessary.
Recently there have been a number of studies performed in children and adults suggesting that interval appendicectomy may not be necessary as very few people actually get appendicitis again. Furthermore, there is a risk of complications, a need for hospital admission and a cost implication associated with interval appendicectomy.
Who can participate?
Children aged between 3 and 16 with a diagnosis of acute appendicitis with appendix mass.
What does the study involve?
We plan to determine whether interval appendicectomy is necessary by randomly assigning children to one of two groups. One group of children will have an interval appendicectomy and the other group will not. Both groups of children will be followed up regularly for at least a year. Any children who do get appendicitis again will be treated appropriately.
What are the possible benefits and risks of participating?
We aim to generate accurate, reliable data which will allow doctors and parents in the future to make an informed decision about their childrens care. If we are right, we may save four out of every five children with this condition from having an operation that they do not need.
Where is the study run from?
Southampton University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2011 to June 2014
Who is funding the study?
BUPA Foundation (UK).
Who is the main contact?
Mr Nigel Hall
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10406
Study information
Scientific title
A prospective randomised evaluation of interval appendicectomy versus conservative follow-up following successful non-operative treatment of appendix mass in children
Acronym
CHINA
Study hypothesis
A proportion of children who have acute appendicitis develop a swelling around the appendix called an appendix mass. From experience, we know that removing the appendix straight away in such children is likely to result in complications and therefore these children are usually treated with intravenous antibiotics rather than with an operation to remove the appendix. Once the child has recovered, most surgeons recommend an operation (called an interval appendicectomy) to remove the appendix several months later in order to prevent the child from getting appendicitis again. However, it is not known whether this operation is actually necessary. Recently there have been a number of studies performed in adults that suggest that interval appendicectomy is not necessary as very few people actually get appendicitis again. Additionally, there is a risk of complications, a need for hospital admission and a cost implication associated with interval appendicectomy.
We plan to determine whether interval appendicectomy is necessary in children by randomly assigning children to 1 of 2 groups. One group of children will have an interval appendicectomy and the other group will not. Both groups of children will be followed up regularly for at least a year. Any children who do get appendicitis again will be treated appropriately. We aim to generate accurate, reliable data which will allow doctors and parents of these children to make an informed decision about their care in the future. If we are right, we may save 80-90% of children with this condition from having an operation that they do not need.
Ethics approval
Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, ref: 10/H05014/67
Study design
Randomised, interventional, prevention, treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
See additional files
Condition
Appendicitis in paediatrics
Intervention
1. Interval appendicectomy
2. Planned interval appendicectomy 6-8 weeks following successful non-operative treatment of appendix mass
3. Watchful waiting
4. Regular (3 monthly) observation for a 1 year period
5. Follow Up Length: 12 month(s)
6. Single randomisation only
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Recurrence of acute appendicitis within 12 months of recruitment
Secondary outcome measures
1. Cost analysis
2. Histology of resected appendix
3. Significant complications during or following interval appendicectomy within 12 months
Overall trial start date
01/03/2010
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of acute appendicitis with appendix mass
2. Appendix mass palpable clinically, during examination under anaesthetic or identified radiologically (ultrasound or CT scan)
3. Have been successfully treated nonoperatively during the acute stage of the illness
4. Aged >3yrs and <16 yrs
5. Male or female
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
UK Sample Size: 100
Participant exclusion criteria
1. Aged less than 3 years or more than 16 years at the time of initial presentation
2. Co-existing gastrointestinal disease e.g. inflammatory bowel disease
3. Presence of major associated abnormalities or immune defect
4. Inability to obtain informed consent
Recruitment start date
08/08/2011
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
BUPA Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/03/2017
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28404154
Publication citations
Additional files
- ISRCTN93815412_PIS_26Apr11_V3.pdf Uploaded 15/12/2016