Ano Fistula, Fistula in Ano
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERExplanation 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.
OTHERStandard explanation
Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.
Sponsors
London North West Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective randomised pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient understanding of fistula anatomy and surgery | 5 minutes | A score obtained using a non-validated questionnaire that assesses the patient's understanding of their fistula anatomy and the treatment that has been proposed. Scores can range from 0 to 16, with a higher score suggesting better understanding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient understanding of their fistula: Patient reported subjective assessment | 1 minute | A self reported score that patients give for how well they feel they have understood their fistula and proposed surgery. Patients rate how well they understand their fistula on a scale of 1-10, where 1 denotes very poor understanding, and 10 equates to excellent understanding. |
| Quality of explanation: Patient reported subjective assessment | 1 minute | Patient reported subjective rating of how well their clinician explained their fistula and surgery to them. Four questions where patients rate how well their fistula was explained on a scale of 1 to 10, with 1 equating to very poor understanding and 10 excellent understanding. An additional question asks the patient if the explanation relieved their anxiety (Yes/No). Responses to individual questions will be reported. |
| Decisional Conflict Scale | 5 minutes | A validated questionnaire that assesses the level of uncertainty a patient has in making a decision. Subscales: Uncertainty: Scores range from 0 (feels extremely certain) to 100 (feels extremely uncertain about best choice) Informed: Scores range from 0 (feels extremely informed) to 100 (extremely uninformed) Values clarity: Scores range from 0 (feels clear about personal values for benefits and risks) to 100 (feels extremely unclear about personal values) Support: Scores range from 0 (feels extremely supported in decision making) to 100 (feels unsupported in decision making) Effective decision: Scores range from 0 (good decision) to 100 (bad decision). The total score is obtained by the addition of each individual score, which is then divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) |
| 3D model utility | 1 minute | Patient reported subjective rating of how useful the 3D model was, using a non- validated questionnaire. This includes 3 questions where patients rate how useful the model is on a scale of 1 to 10, with 1 equating to not very useful, and 10 being very useful. The final question asks patients if they would like to see models in future consultations (Yes/No). Responses to individual questions will be presented. |
Countries
United Kingdom
Outcome results
None listed