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

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): Study protocol for a randomised controlled Trial
CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): Study protocol for a randomised controlled Trial
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.
Appendicitis, non-operative treatment, paediatric surgery, appendicectomy, feasibility
1745-6215
1-10
Hutchings, Natalie
b91b8fbd-3eb6-4108-8e8e-ccb78b309a44
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Walker, Erin
882a68df-4f38-49cc-95ac-01a28492dff3
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
van't Hoff, William
2e765a4d-d3f4-43ce-aa2e-f597cd4f6c31
Young, Bridget
f950d6c8-951a-461a-bf69-5ed67bba2a73
Crawley, Esther M.
14939e46-323c-45ae-bb61-129edc0429ea
Eaton, Simon
e14103c2-c06a-45e6-87fe-2358a3371283
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Sherratt, Frances C.
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Beasant, Lucy
a080197b-17cd-46eb-8622-b9b85f072268
Corbett, Harriet
eebbc3a7-c4ea-4415-9e29-571fd3fb9e44
Stanton, Michael P.
0f6a6113-57d0-4c8a-b518-cd9aea3dc998
Grist, Simon
533d6e8a-ccb6-431a-af93-cac634f87d17
Dixon, Elizabeth
f2e33dd1-36f5-4a82-8d3b-ebd5b14cb675
Hall, Nigel J.
6919e8af-3890-42c1-98a7-c110791957cf
Hutchings, Natalie
b91b8fbd-3eb6-4108-8e8e-ccb78b309a44
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Walker, Erin
882a68df-4f38-49cc-95ac-01a28492dff3
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
van't Hoff, William
2e765a4d-d3f4-43ce-aa2e-f597cd4f6c31
Young, Bridget
f950d6c8-951a-461a-bf69-5ed67bba2a73
Crawley, Esther M.
14939e46-323c-45ae-bb61-129edc0429ea
Eaton, Simon
e14103c2-c06a-45e6-87fe-2358a3371283
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Sherratt, Frances C.
15d60c07-ff52-4a37-b51e-5de8b39d4624
Beasant, Lucy
a080197b-17cd-46eb-8622-b9b85f072268
Corbett, Harriet
eebbc3a7-c4ea-4415-9e29-571fd3fb9e44
Stanton, Michael P.
0f6a6113-57d0-4c8a-b518-cd9aea3dc998
Grist, Simon
533d6e8a-ccb6-431a-af93-cac634f87d17
Dixon, Elizabeth
f2e33dd1-36f5-4a82-8d3b-ebd5b14cb675
Hall, Nigel J.
6919e8af-3890-42c1-98a7-c110791957cf

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

Record type: Article

Abstract

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.

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CONTRACT Protocol Publication_revision2 clean - Accepted Manuscript
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More information

Accepted/In Press date: 2 February 2018
e-pub ahead of print date: 2 March 2018
Published date: 2 March 2018
Keywords: Appendicitis, non-operative treatment, paediatric surgery, appendicectomy, feasibility

Identifiers

Local EPrints ID: 418256
URI: http://eprints.soton.ac.uk/id/eprint/418256
ISSN: 1745-6215
PURE UUID: 864d6291-468f-407b-889c-42f8f6d3d7b7
ORCID for Isabel Reading: ORCID iD orcid.org/0000-0002-1457-6532
ORCID for Nigel J. Hall: ORCID iD orcid.org/0000-0001-8570-9374

Catalogue record

Date deposited: 26 Feb 2018 17:30
Last modified: 18 Feb 2021 17:16

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Contributors

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

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