NCT04069728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

September 20, 2021

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

August 23, 2019

Last Update Submit

September 17, 2021

Conditions

Fistula in AnoAno Fistula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient understanding of their fistula: Patient reported subjective assessment

    1 minute

  • Quality of explanation: Patient reported subjective assessment

    1 minute

  • Decisional Conflict Scale

    5 minutes

  • 3D model utility

    1 minute

Study Arms (2)

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

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

Other: Explanation with 3D printed fistula model

Interventions

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.

Clinic appointment with 3D model
Standard explanationOTHER

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

Standard clinic appointment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London North West University Healthcare NHS Trust

Harrow, London, HA1 3UJ, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 28214968BACKGROUND

  • 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.

    PMID: 29854001BACKGROUND

  • 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.

    PMID: 26162845BACKGROUND

  • 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.

    PMID: 30900439BACKGROUND

  • 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.

    PMID: 28387702BACKGROUND

  • Iqbal 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.

    PMID: 38235831DERIVED

Related Links

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mr Tozer

    LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective randomised pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

November 2, 2020

Primary Completion

August 2, 2021

Study Completion

August 2, 2021

Last Updated

September 20, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)