Clinical trial NCT04069728: The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
Official title: The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula in Ano
Ano Fistula
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised pilot study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient understanding of fistula anatomy and surgery
timeFrame: 5 minutes
Secondary outcomes:
measure: Patient understanding of their fistula: Patient reported subjective assessment
timeFrame: 1 minute
measure: Quality of explanation: Patient reported subjective assessment
timeFrame: 1 minute
measure: Decisional Conflict Scale
timeFrame: 5 minutes
measure: 3D model utility
timeFrame: 1 minute
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
state: London
Study officials:
affiliation: LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
name: Mr Tozer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biglino G, Koniordou D, Gasparini M, Capelli C, Leaver LK, Khambadkone S, Schievano S, Taylor AM, Wray J. Piloting the Use of Patient-Specific Cardiac Models as a Novel Tool to Facilitate Communication During Cinical Consultations. Pediatr Cardiol. 2017 Apr;38(4):813-818. doi: 10.1007/s00246-017-1586-9. Epub 2017 Feb 18.
citation: Sahnan K, Adegbola SO, Tozer PJ, Patel U, Ilangovan R, Warusavitarne J, Faiz OD, Hart AL, Phillips RKS, Lung PFC. Innovation in the imaging perianal fistula: a step towards personalised medicine. Therap Adv Gastroenterol. 2018 May 24;11:1756284818775060. doi: 10.1177/1756284818775060. eCollection 2018.
citation: Bernhard JC, Isotani S, Matsugasumi T, Duddalwar V, Hung AJ, Suer E, Baco E, Satkunasivam R, Djaladat H, Metcalfe C, Hu B, Wong K, Park D, Nguyen M, Hwang D, Bazargani ST, de Castro Abreu AL, Aron M, Ukimura O, Gill IS. Personalized 3D printed model of kidney and tumor anatomy: a useful tool for patient education. World J Urol. 2016 Mar;34(3):337-45. doi: 10.1007/s00345-015-1632-2. Epub 2015 Jul 11.
citation: Roy M, Novak CB, Urbach DR, McCabe SJ, von Schroeder HP, Okrainec K. Decisional conflict in surgical patients: Should surgeons care? Can J Surg. 2019 Mar 22;62(3):1-3. Online ahead of print.
citation: Sander IM, Liepert TT, Doney EL, Leevy WM, Liepert DR. Patient Education for Endoscopic Sinus Surgery: Preliminary Experience Using 3D-Printed Clinical Imaging Data. J Funct Biomater. 2017 Apr 7;8(2):13. doi: 10.3390/jfb8020013.