Journal Article

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial

Stanton, Michael P., Sherratt, Frances C., Corbett, Harriet, Eaton, Simon, Hutchings, Natalie, Beasant, Lucy, Wood, Wendy, van’t Hoff, William, Walker, Erin, Chorozoglou, Maria, Young, Bridget, Hall, Nigel J., Grist, Simon, Dixon, Elizabeth, Reading, Isabel, Crawley, Esther M., Blazeby, Jane M.

2018

Overview

Background Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. Methods/design The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4–15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. Discussion In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. Trial registration ISRCTN15830435 . Registered on 8 February 2017.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / Adolescent / Age Factors / Analysis / Anti-Bacterial Agents - adverse effects / Anti-Bacterial Agents - economics / Anti-Bacterial Agents - therapeutic use / Antibiotics / Appendectomy / Appendicectomy / Appendicitis / Appendicitis - diagnosis / Appendicitis - economics / Appendicitis - therapy / Biomedicine / Care and treatment / Child / Child, Preschool / Children / Clinical trials / Comparative analysis / Conservative Treatment - adverse effects / Conservative Treatment - economics / Conservative Treatment - methods / Cost control / Cost-Benefit Analysis / England / Feasibility / Feasibility Studies / Female / Health aspects / Health Care Costs / Health Sciences / Humans / Male / Medicine / Medicine & Public Health / Multicenter Studies as Topic / Non-operative treatment / Paediatric surgery / Patients / Pediatrics / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Study Protocol / Surgery / Systematic review / Time Factors / Treatment Outcome