The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making (3DAF)

London North West Healthcare NHS Trust

Status: Completed

Conditions: Ano Fistula; Fistula in Ano

Treatments: Other: Standard explanation; Other: Explanation with 3D printed fistula model

Study type: Interventional

Funder types: Other

Identifiers

NCT04069728

RD19/027

Details and patient eligibility

About

An anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. 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. This study will determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician's explanation is and how this impacts the decision-making process using standard explanation with 2D images, versus a 3D printed model of a fistula.

Full description

Previous work has established a method of using traditional two-dimensional MR images to construct and print 3D models of perianal fistula, however the clinical utility of these models in the outpatient setting and their impact on patient knowledge of disease have not yet been assessed. This study is aimed at understanding how the use of 3D printed models can influence patient understanding of disease and support them in making decisions regarding treatment.

Participants attending routine outpatient appointments 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients
• Aged ≥18 years old
• Patients who are new referrals to complex fistula clinic
• Patients with an idiopathic or Crohn's perianal fistula
• Patients with an intersphincteric or transsphincteric fistula according to Park's classification
• Patients who have had MR imaging of their anal fistula prior to consultation
• Able to give full informed consent

Exclusion criteria

Patients < 18 years

• Patients with a rectovaginal or pouch fistula
• Fistula secondary to malignancy or radiation
• Suprasphincteric or extrasphincteric fistulas
• Follow up patients
• Patients who have no prior MR imaging of their fistula Patients who do not have the capacity to consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard clinic appointment

Other group

Description:

Patients who undergo a routine clinic outpatient appointment using standard explanation of their fistula with words, diagrams and MRI images, as per Consultant preference

Treatment:

Other: Standard explanation

Clinic appointment with 3D model

Experimental group

Description:

Patients who undergo a routine clinic outpatient appointment using a 3D printed model to assist explanation of their fistula

Treatment:

Other: Explanation with 3D printed fistula model