3DAF
Research type
Research Study
Full title
The impact of 3D anal fistula models on patient understanding and decision making
IRAS ID
266053
Contact name
Nusrat Iqbal
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Clinicaltrials.gov Identifier
Submitted- pending, ClinicalTrials.gov
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
An anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. They occur in approximately 2 per 10,000 patients per year in England causing symptoms such as pain and discharge that can significantly impair quality of life. Fistulas can vary in their complexity and can be challenging to treat, due to the anatomical relation to the anal sphincter complex that controls continence. In addition, fistulas can display complex features such as branches, cavities and horseshoes; where the tract travels radially around the anal canal. All these features have a role in determining the most appropriate surgical treatment option, and are key to understanding the surgical decision-making process.
In order to provide informed consent for a given procedure, patients must be able to understand the nature of the treatment being proposed, its risks and benefits and its functional impact. Where this relates to perianal fistula surgery, patients are required to have a basic understanding of fistula anatomy. This can be difficult to explain using two-dimensional diagrams and images. We propose a study to determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician’s explanation was and how this impacts the decision-making process using standard explanation with 2D images, versus a 3D printed model of a fistula.
Participants attending routine outpatient appointments at St Mark’s Hospital will have their fistula explained to them using either a standard explanation, or a 3D printed model of a fistula. They will complete a short series of questionnaires and their answers will be analysed to determine if there is any benefit of using 3D models in a clinical consultation.REC name
Wales REC 6
REC reference
19/WA/0269
Date of REC Opinion
23 Sep 2019
REC opinion
Favourable Opinion