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Recruiting to surgical trials in the emergency setting: using a mixed methods study to understand clinician and patient perspectives

Twiddy, Maureen; Birtwistle, Jacqueline; Edmondson, Amanda; Croft, Julie; Gordon, Kathryn; Meads, David; Burke, Dermot; Griffiths, Ben; Rose, Azmina; Sagar, Peter; Stocken, Deborah; Brown, Julia M B; Harji, Deena


Jacqueline Birtwistle

Amanda Edmondson

Julie Croft

Kathryn Gordon

David Meads

Dermot Burke

Ben Griffiths

Azmina Rose

Peter Sagar

Deborah Stocken

Julia M B Brown

Deena Harji


Background: Undertaking randomized clinical trials (RCTs) in emergency surgical settings is associated with methodological and practical challenges. This study explored patients' and clinicians' perspectives associated with the conduct of an RCT comparing laparoscopic and open colorectal surgery in the acute setting. Methods: All eligible patients screened and enrolled for the 'Laparoscopic versus open colorectal surgery in the acute setting (LaCeS)' multicentre, randomized clinical feasibility trial in five UK NHS Trusts were invited to respond to a survey. Patients and healthcare professionals were also invited to take part in semi-structured interviews. Survey and interviews explored the acceptability of the feasibility trial. Interviews were audio recorded, transcribed verbatim, and analysed using thematic analysis. Survey data were analysed descriptively to assess patient views of the trial and intervention. Results: Out of 72 patients enrolled for the LaCeS RCT, survey data were collected from 28 patients (38.9 per cent), and interviews were conducted with 16 patients and 14 healthcare professionals. Thirteen out of 28 patients (46 per cent) had treatment preferences but these were not strong enough to deter participation. Twelve of the patients interviewed believed that their surgeon preferred laparoscopic surgery, but this did not deter them from participating in the trial. Half of the surgeons interviewed expressed the view that laparoscopic surgery was of benefit in this setting, but recognized that the need for research evidence outweighed their personal treatment preferences. Eight of the 14 recruiters reported that the emergency setting affected recruitment, especially in centres with fewer recruiting surgeons. Interviewees reported that recruitment was helped significantly by using surgical trainees to consent patients. Conclusion: This study identified specific challenges for the LaCeS trial design to address and adds significant insights to our understanding of recruiting to emergency surgical trials more broadly.


Twiddy, M., Birtwistle, J., Edmondson, A., Croft, J., Gordon, K., Meads, D., …Harji, D. (2022). Recruiting to surgical trials in the emergency setting: using a mixed methods study to understand clinician and patient perspectives. BJS Open, 6(6), Article zrac137.

Journal Article Type Article
Acceptance Date Sep 29, 2022
Online Publication Date Nov 23, 2022
Publication Date 2022-12
Deposit Date Sep 30, 2022
Publicly Available Date Nov 25, 2022
Journal BJS Open
Print ISSN 2474-9842
Electronic ISSN 2474-9842
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 6
Issue 6
Article Number zrac137
Public URL


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Copyright Statement
© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.<br /> This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which<br /> permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

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