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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-08-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fistula in Ano Ano Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised pilot study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard clinic appointment

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

Group Type OTHER

Standard explanation

Intervention Type OTHER

Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.

Clinic appointment with 3D model

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

Group Type EXPERIMENTAL

Explanation with 3D printed fistula model

Intervention Type OTHER

Explanation of fistula and surgery using a 3D printed model of an anal fistula that depicts the anatomy of the anal canal, the path of the anal fistula and its relation to anatomic structures.

Interventions

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Explanation with 3D printed fistula model

Explanation of fistula and surgery using a 3D printed model of an anal fistula that depicts the anatomy of the anal canal, the path of the anal fistula and its relation to anatomic structures.

Intervention Type OTHER

Standard explanation

Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No