Skip to main navigationSkip to main content
The University of Southampton
Southampton Clinical Trials Unit

CONTRACT

Trial Name

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

Description

The study includes a number of inter-related work streams:

1. A randomised controlled feasibility trial of children comparing a non-operative treatment pathway with appendicectomy. Both groups of children will receive broad spectrum antibiotics from the point of enrolment; one group of children will undergo urgent appendicectomy, the other will be treated non-operatively with continuation of broad spectrum intravenous antibiotics. All patients will be followed up with visits at 6 weeks, 3 months and 6 months.

2. A detailed program of qualitative and quantitative research embedded within the above feasibility trial which will be used to optimise the design and conduct of a future RCT of non-operative treatment versus appendicectomy in the treatment of acute uncomplicated appendicitis in children.


3. The development of a Core Outcome Set for the non-operative treatment of children with uncomplicated acute appendicitis for use in our future trial and by the wider research community.

 

Objectives

Primary Objective:

Assess whether it is feasible to conduct a multi-centre randomised controlled trial testing the effectiveness and cost-effectiveness of a non-operative treatment pathway for the treatment of acute uncomplicated appendicitis in children.
Secondary Objectives:

Assess the willingness of parents and children to be enrolled in, and surgeons to recruit to a randomised study comparing operative versus non-operative treatment and identify anticipated recruitment rate.
Identify strategies to optimise surgeon-family communication to inform the future RCT.
Enhance the design of a future RCT from the perspectives of stakeholders at participating sites (children, parents, surgeons and nurses)
Identify what core outcomes family members and surgeons regard as important to measure in a future RCT and to develop a core outcome set
Assess the equipoise and willingness of UK paediatric surgeons to participate in a future RCT
Generate data to allow for the design of a definitive RCT, including sample size calculation and identification of key cost drivers and other parameters necessary to perform a full economic analysis
Examine clinical outcomes of children with acute appendicitis treated without an operation including an initial assessment of efficacy and safety of this treatment pathway in our centres
Ensure the whole of the research programme is well informed by a group of children and parents, our SSAG

Design

Mixed methods feasibility study comprising:

Randomised controlled trial
Embedded and parallel qualitative and survey study
Development of core outcome set

Status

Complete

Population

No target as feasibility of recruitment is being tested – patients will be recruited over 12 months (approx. 65 pts) 

Publication

Hutchings, N., Wood, W., Reading, I., Walker, E., Blazeby, J. M., van't Hoff, W., ... Hall, N. J. (2018). CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): Study protocol for a randomised controlled Trial. Trials, 19(1), 1-10. [153]. DOI: 10.1186/s13063-018-2520-z, 10.1186/s13063-018-2520-z 

 

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk

Privacy Settings