Fistula in Ano3DAFNCT04069728
The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
A study testing Explanation with 3D printed fistula model and Standard explanation in people with Fistula in Ano and Ano Fistula, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fistula in Ano, Ano Fistula
- What is being tested?
- Explanation with 3D printed fistula model and Standard explanation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2020to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London North West University Healthcare NHS Trust
Harrow, London, HA1 3UJ
About this study
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.
Read the 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.
- Conditions
- Fistula in Ano, Ano Fistula
- Being tested
- Explanation with 3D printed fistula model, Standard explanation
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explanation with 3D printed fistula modelOther
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 explanationOther
Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinic appointment | Other | Patients who undergo a routine clinic outpatient appointment using standard explanation of their fistula with words, diagrams and MRI images, as per Consultant preference Receives: Other: Standard explanation |
| Clinic appointment with 3D model | Experimental | Patients who undergo a routine clinic outpatient appointment using a 3D printed model to assist explanation of their fistula Receives: Other: Explanation with 3D printed fistula model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (4)
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.
Measured: 1 minute
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.
Measured: 1 minute
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)
Measured: 5 minutes
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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Nov 2020
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mr Tozer, Principal investigator, LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069728
- Sponsor's protocol ID
- RD19/027
- Acronym
- 3DAF
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28214968Sahnan 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. Ther Adv Gastroenterol. 2018 May 24;11:1756284818775060. doi: 10.1177/1756284818775060. eCollection 2018.
PubMed 29854001Bernhard 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.
PubMed 26162845Roy 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.
PubMed 30900439Sander 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.
PubMed 28387702Iqbal N, Fletcher J, Bassett P, Hart A, Lung P, Tozer P. Exploring methods of improving patient understanding and communication in a complex anal fistula clinic: results from a randomized controlled feasibility study. Colorectal Dis. 2024 Mar;26(3):518-526. doi: 10.1111/codi.16861. Epub 2024 Jan 18.
PubMed 38235831
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
- ClinicalTrials.gov ID
- NCT04069728
- Acronym / sponsor ID
- 3DAF / RD19/027
- Conditions
- Fistula in Ano, Ano Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised pilot study
| Arm | Type | Receives |
|---|---|---|
| Standard clinic appointment | Other | Other: Standard explanationPatients who undergo a routine clinic outpatient appointment using standard explanation of their fistula with words, diagrams and MRI images, as per Consultant preference |
| Clinic appointment with 3D model | Experimental | Other: Explanation with 3D printed fistula modelPatients who undergo a routine clinic outpatient appointment using a 3D printed model to assist explanation of their fistula |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Patients < 18 years
- Patients with a rectovaginal or pouch fistula
- Fistula secondary to malignancy or radiation
- Suprasphincteric or extrasphincteric fistulas
- Follow up patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explanation with 3D printed fistula modelExplanation 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. | Other | Clinic appointment with 3D model |
| Standard explanationExplanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care. | Other | Standard clinic appointment |
Primary outcome
Patient understanding of fistula anatomy and surgery
Time frame: 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.
4 secondary outcomes
Patient understanding of their fistula: Patient reported subjective assessment
Time frame: 1 minute
Quality of explanation: Patient reported subjective assessment
Time frame: 1 minute
Decisional Conflict Scale
Time frame: 5 minutes
3D model utility
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background: PubMed 28214968Biglino 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.
- Background: PubMed 29854001Sahnan 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. Ther Adv Gastroenterol. 2018 May 24;11:1756284818775060. doi: 10.1177/1756284818775060. eCollection 2018.
- Background: PubMed 26162845Bernhard 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.
- Background: PubMed 30900439Roy 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.
- Background: PubMed 28387702Sander 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.
- Derived from this study: PubMed 38235831Iqbal N, Fletcher J, Bassett P, Hart A, Lung P, Tozer P. Exploring methods of improving patient understanding and communication in a complex anal fistula clinic: results from a randomized controlled feasibility study. Colorectal Dis. 2024 Mar;26(3):518-526. doi: 10.1111/codi.16861. Epub 2024 Jan 18.
- Decisional conflict scale questionnaire and user manualLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr Tozer principal investigator
LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explanation with 3D printed fistula model and Standard explanation in people with Fistula in Ano and Ano Fistula, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient understanding of fistula anatomy and surgery (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069728, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.