Extrait

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) [email protected] 2. Mr Nigel Hall (scientific) [email protected]

Critère d'inclusion

• Specialty: Children, Primary sub-specialty: Gastroenterology, Hepatology and Nutrition; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of appendix

Liens

• isrctn