Fistula in Ano Clinical Trial
— 3DAFOfficial title:
The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
Verified date | December 2020 |
Source | London North West Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | London North West University Healthcare NHS Trust | Harrow | London |
Lead Sponsor | Collaborator |
---|---|
London North West Healthcare NHS Trust |
United Kingdom,
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
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 |
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