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

Fistula in Ano Clinical Trial

— 3DAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069728
• Other study ID #: RD19/027
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: August 2, 2021

Study information

• Verified date: December 2020
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ano Fistula
• Fistula
• Fistula in Ano
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
United Kingdom	London North West University Healthcare NHS Trust	Harrow	London

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. [Epub ahead of print] — View 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. — View 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). pii: E13. doi: 10.3390/jfb8020013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient understanding of fistula anatomy and surgery	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.	5 minutes
Secondary	Patient understanding of their fistula: Patient reported subjective assessment	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.	1 minute
Secondary	Quality of explanation: Patient reported subjective assessment	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.	1 minute
Secondary	Decisional Conflict Scale	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)	5 minutes
Secondary	3D model utility	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.	1 minute

External Links

•   Decisional conflict scale questionnaire and user manual