Condition category
Infections and Infestations
Date applied
29/07/2011
Date assigned
29/07/2011
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 study starting and how long is it expected to run for?
This study will run from June 2011 to June 2014.

Who is funding the study?
BUPA Foundation (UK).

Who is the main contact?
Mr Nigel Hall

Trial website

http://www.chinastudy.org.uk

Contact information

Type

Scientific

Primary contact

Mr Nigel Hall

ORCID ID

Contact details

Tremona Road
Southampton
SO16 6YD
United Kingdom

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

Not available in web format, please use the contact details below to request a patient information sheet

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/06/2011

Overall trial end date

01/06/2014

Reason abandoned

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

01/06/2011

Recruitment end date

01/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tremona Road
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

http://www.suht.nhs.uk/home.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

BUPA Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes