Perianal Crohn’s disease & Patient informational preferences
Research type
Research Study
Full title
Patient informational preferences in surgical therapies of perianal Crohn’s disease
IRAS ID
230885
Contact name
Matthew Lee
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Crohn’s disease in an inflammatory condition which can affect any part of the gastrointestinal tract. It typically follows one of common behaviour patterns; inflammatory, structuring or penetrating. The penetrating phenotype involves connections of the bowel to other parts of bowel or the skin (a fistula). Around one in three patients with Crohn’s disease will develop a fistula around their back passage (a perianal fistula). This condition is challenging to manage, and usually requires a combination of medical therapy with repeated operations. There are a number of surgical options to treat a fistula. Decisions about treatments may be preference sensitive.
The aim of this study is to assess patient preferences on content and format of a patient decision aid for surgical treatments in perianal Crohn’s disease. This study intends to include a focus-group based pilot, then a cross-sectional survey of patients treated for perianal Crohn’s disease at centres across the UK. The focus group will be held in Sheffield Teaching Hospitals as a method of piloting the questionnaire. During the group participants will be provided with a copy of the questionnaire and allowed 10-15 minutes to review this. A semi-structured discussion will follow. Written notes will be taken during the focus group to record feedback. Suggestions and feedback from the focus group will be taken into account and the questionnaire will be modified appropriately. Following this centres around the UK will identify potential participants who will be sent a copy of the questionnaire, along with a template letter. This pack will include a prepaid envelope for return of the questionnaire to the central team. The return of the questionnaire will constitute implied consent. Accordingly the questionnaire includes a statement which specifies that by returning the questionnaire they are giving consent for their anonymised data to be used in this study
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1446
Date of REC Opinion
23 Aug 2017
REC opinion
Favourable Opinion