CONservative TReatment of Appendicitis in Children a randomised controlled Trial CONTRACT (Feasibility study)

Hall N J, Sherratt F C, Eaton S, Reading I, Walker E, Chorozoglou M, Beasant L, Wood W, Stanton M, Corbett H J, Rex D, Hutchings N, Dixon E, Grist S, Hoff WV, Crawley E, Blazeby J, Young B
Record ID 32016000922
English
Authors' objectives: Can you treat my child without an operation? is frequently asked by parents of children with acute appendicitis, the commonest condition in children treated with emergency surgery. Currently the answer is No as the gold-standard treatment is an operation called an appendicectomy in which the appendix is removed. Recently, however, it has become clear in adults that antibiotics may be as good as an operation for acute appendicitis and the majority of adults can avoid an operation altogether. We do not know whether this is the case for children with appendicitis but we believe the timing is right for a careful research study to find out the answer. The overall aim of our research is to answer the question: Is surgery necessary for children with acute appendicitis? To answer our question we plan to perform a large study comparing 2 groups of children with appendicitis one group will have surgery and the other will be treated with antibiotics. However before we do this we need to see if running such a study will be achievable. It would be wrong to commit significant resources to such a study if it is unlikely to be possible to complete. This project is therefore a feasibility study in 3 related parts. We will perform a small trial which will randomly allocate children with appendicitis to have either an appendicectomy or non-operative treatment with antibiotics. The study will be carried out in 3 specialist Children s Surgery centres and last for 1 year. We will see how many patients and families are willing to join the study and will look at how well children in the study recover. This will give us an indication of how many children we may be able to recruit into our future larger trial and how the outcomes of non-operative treatment compare with an operation. Although this may give us an idea of whether it is possible to safely treat children who have appendicitis with antibiotics, it will not provide a definitive answer. Embedded within this trial we will carry out some other research to find out the reasons for wanting or not wanting to join a trial such as this through careful discussion with patients and their parents. In those who have been involved we will find out how they found the experience. In particular we will ask what we can do to improve the trial from the families perspective. We will assess surgeon willingness to recruit patients into the study as measured by recruitment rates and explore clinician attitudes to the study by discussion. We will approach surgeons in the centres involved in the study and also across the whole of the UK. We envisage that all of this information will enable us to improve the design of our future trial so that it has the greatest possible chance of success. Finally we will ask parents, patients, and surgeons what they think are the most important outcomes for children with acute appendicitis treated without an operation. We will develop an essential list of outcomes that should be measured. We will measure these in our future trial, so we can be certain we record important outcomes that are most likely to influence parental decisions and surgeon practice in the future. All of the information gathered from the 3 parts of our study will enable us to design and complete a larger study in the future. This larger study is what will be needed to demonstrate whether the two types of treatment (surgery or antibiotics) are as effective as each other
Details
Project Status: Completed
Year Published: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Appendectomy
  • Anti-Bacterial Agents
  • Child
  • Feasibility Studies
  • Treatment Outcome
  • Conservative Treatment
  • Unnecessary Procedures
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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