The CHildren’s INterval Appendicectomy (CHINA) Study

ISRCTN ISRCTN93815412
DOI https://doi.org/10.1186/ISRCTN93815412
Secondary identifying numbers 10406
Submission date
29/07/2011
Registration date
29/07/2011
Last edited
18/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 children’s 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

Study website

Contact information

Mr Nigel Hall
Scientific

Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Study designRandomised, interventional, prevention, treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet ISRCTN93815412_PIS_26Apr11_V3.pdf
Scientific titleA prospective randomised evaluation of interval appendicectomy versus conservative follow-up following successful non-operative treatment of appendix mass in children
Study acronymCHINA
Study objectivesA 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(s)Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, ref: 10/H05014/67
Health condition(s) or problem(s) studiedAppendicitis in paediatrics
Intervention1. 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 typeProcedure/Surgery
Primary outcome measureRecurrence of acute appendicitis within 12 months of recruitment
Secondary outcome measures1. Cost analysis
2. Histology of resected appendix
3. Significant complications during or following interval appendicectomy within 12 months
Overall study start date01/03/2010
Completion date01/10/2016

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit16 Years
SexBoth
Target number of participantsUK Sample Size: 100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/08/2011
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website http://www.suht.nhs.uk/home.aspx
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Hospital/treatment centre

BUPA Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
United Kingdom

Results and Publications

Intention to publish date31/03/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a peer reviewed journal.
IPD sharing planThe 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?
Participant information sheet version V3 26/04/2011 15/12/2016 No Yes
Results article results 01/04/2017 Yes No

Additional files

ISRCTN93815412_PIS_26Apr11_V3.pdf
Uploaded 15/12/2016

Editorial Notes

18/04/2017: Publication reference added.
15/12/2016: The overall trial dates have been updated from 01/06/2011 - 01/06/2014 to 01/03/2010 - 01/10/2016 and the recruitment dates have been updated from 01/06/2011 - 01/06/2014 to 08/08/2011 - 31/12/2014. In addition, the publication and dissemination plan, IPD sharing plan and participant information sheet have been added.