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The University of Southampton
Southampton Clinical Trials Unit

CONTRACT

Title

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

Trial Design

Mixed methods feasibility study comprising:

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

Trial Status

Closed to recruitment / In follow up

Population

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

Considerations

Children (aged 4-15 years) with a clinical diagnosis of acute uncomplicated appendicitis, either with or without radiological assessment, which prior to study commencement would be treated with appendicectomy will be included. Written informed parental consent, with child assent if appropriate will be required.

Senior Trial Manager:

Liz Dixon (023 8120 5331)

Trial Manager:

Natalie Hutchings (023 8120 4128)

Clinical Data Coordinator:

Peter Navin (023 8120 5321)

Email:

contract@soton.ac.uk

 

Essential Trial Documents

CONTRACT Certificate v1 14.10.16

CONTRACT Consent form v3 21.06.17

CONTRACT Discharge leaflet v1 06.10.16_for sites

CONTRACT Discharge Pack Cover Letter v1 14.10.16

CONTRACT GP Letter v1 06.10.16

CONTRACT Parent Info Sheet v5 13.11.17

CONTRACT Patient Diary Card v2 11.01.17

CONTRACT Poster v2 12.07.17

CONTRACT Protocol v4 08-Mar-2018

CONTRACT Teenagers Info Sheet v3 13.11.17

CONTRACT Young Person Info Sheet v2 11.01.17

CONTRACT Compliments Slip v1 07.03.18

Investigator Site File

Instructions for completion of Serious Adverse Event Reporting - Non-CTIMP v1 20.12.16

Investigator Site File Index v1 08-Dec-16

Master Patient List v1 08-Dec-2016

Non-CTIMP SAE Report Form v1 05.01.17

Patient Screening and Recruitment Log v1 08-Dec-2016

PI Protocol Acknowlegment Form_v1

Site Training Record v1 28.11.16

Site Visit Log v1 20.12.16

CONTRACT eCRF Completion Guidelines SCTU v1 23.03.17

CONTRACT TENALEA User Manual v1 27.02.17

Questionnaires

CONTRACT CHU-9D Proxy

CONTRACT CHU-9D

CONTRACT CSRI v1 20.10.16

EQ-5D-5L Proxy v1 04.01.17

EQ-5D-5L v1 04.01.17

Communication Sub Study

CONTRACT Coms Substudy Consent form v2 23.11.16

CONTRACT Coms Substudy HP consent form v1 10.10.16

CONTRACT Coms Substudy HP PIS v1 10.10.16

CONTRACT Coms Substudy Parent PIS v1 07.10.16

CONTRACT Coms Substudy Teen PIS v1 07.10.16

CONTRACT Coms Substudy YP PIS v1 07.10.16

Core Outcome Set Development Study

CONTRACT COS Cover Letter (parent) v2 14.08.17

CONTRACT COS Cover Letter (young adults) v1 14.08.17

CONTRACT COS Cover Letter (YP) v2 14.08.17

CONTRACT COS Parent Information Sheet v2 14.08.17

CONTRACT COS Young Adult Information Sheet v1 14.08.17

CONTRACT COS Young People Information Sheet v2 14.08.17

CONTRACT Videos:

Patient Information

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Core Outcome:

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