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CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT)

Nigel J Hall1,2, Simon Eaton3, Frances C Sherratt4

  • 1University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK n.j.hall@soton.ac.uk.

Archives of Disease in Childhood
|January 14, 2021
PubMed

Insights

Conducting a trial on non-operative treatment versus appendicectomy for childhood appendicitis is feasible. Recruitment improved with targeted training, showing safe and acceptable outcomes for both treatment pathways.

Area of Science:

  • Pediatric Surgery
  • Clinical Trials
  • Gastroenterology

Background:

  • Acute appendicitis is common in children.
  • Appendicectomy is the standard surgical treatment.
  • Non-operative management with antibiotics is an alternative being explored.

Purpose of the Study:

  • To assess the feasibility of a multicentre randomized controlled trial (RCT).
  • To compare non-operative treatment with appendicectomy for uncomplicated acute appendicitis in children.
  • To evaluate the effectiveness and cost-effectiveness of these pathways.

Main Methods:

  • A feasibility RCT conducted in three UK specialist pediatric surgery centers.
  • Included children aged 4-15 years with uncomplicated acute appendicitis.
  • Interventions were appendicectomy or a non-operative pathway (antibiotics and observation).

Main Results:

  • Recruitment feasibility was demonstrated, with 50% of eligible patients agreeing to participate.
  • Repeated recruiter training increased recruitment rates from 38% to 72%.
  • High adherence, acceptable safety, and satisfactory follow-up were observed for both treatment pathways.

Conclusions:

  • A multicentre RCT comparing non-operative treatment with appendicectomy for childhood appendicitis is feasible.
  • The study provides a foundation for a definitive trial on effectiveness and cost-effectiveness.
  • Non-operative management appears safe and feasible in this pediatric population.
Abstract

Keywords:
gastroenterologyhealth services researchqualitative researchtherapeutics

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