Status:

COMPLETED

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

Lead Sponsor:

London North West Healthcare NHS Trust

Conditions:

Fistula in Ano

Ano Fistula

Eligibility:

All Genders

18-80 years

Phase:

NA

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...

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 outpatie...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 2 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 2 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04069728

Start Date

November 2 2020

End Date

August 2 2021

Last Update

September 20 2021

Active Locations (1)

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London North West University Healthcare NHS Trust

Harrow, London, United Kingdom, HA1 3UJ