Status:
TERMINATED
Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula
Lead Sponsor:
London North West Healthcare NHS Trust
Conditions:
Fistula in Ano
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and rad...
Detailed Description
Perianal fistula is a challenging condition for colorectal surgeons. Achieving a favourable balance between healing and incontinence is the key to success. Surgeons have adopted many methods to close ...
Eligibility Criteria
Inclusion
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent
- Patients who are willing and competent to fill in questionnaires and undergo investigations at various time points during the study
- Patients with an idiopathic extra and trans-sphincteric perianal fistula.
Exclusion
- Patients aged less than 18 or \>80 years.
- Patients unfit to undergo general or spinal anaesthesia.
- Patients with a supra-levator fistula.
- Patients with a rectovaginal fistula.
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
- Patients with a fistula secondary to trauma, foreign body, developmental cyst or pelvic irradiation.
- Patients who are immunosuppressed.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03381365
Start Date
September 1 2016
End Date
December 31 2018
Last Update
January 18 2020
Active Locations (1)
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1
London North West Healthcare NHS Trust
London, United Kingdom, HA1 3UJ