Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula

Fistula in Ano Clinical Trial

Official title:

A Pilot Study to Assess the Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening (Curaseal AF) as a Treatment for Perianal Fistula

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03381365
• Other study ID #: 195923
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2017
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 radiologically with MR imaging.

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 off this abnormal tract, which include laying opening, use of setons, advancement flaps and permanent stoma. A more recent approach has been the use of devices or substances to block the tract in the hope that it will seal off. Most of the devices that have been used to close the tract have not proved to be as effective in healing as a lay open with high rates of fistula persistence. A major failure of the devices has been their early expulsion and their inability to seal off the internal opening.

The new Curaseal plug may be able to overcome these shortcomings. This plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure.

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 radiologically with MR imaging.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano

Intervention

Device:
• CuraSeal Percutaneous Intraluminal Closure System

Locations

Country	Name	City	State
United Kingdom	London North West Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fistula healing	clinical and radiological healing	1 year
Secondary	adverse effects or perioperative compilations related to device		within first year