Fistula in Ano
Conditions
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 radiologically with MR imaging.
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 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.
Interventions
DEVICECuraSeal Percutaneous Intraluminal Closure System
Sponsors
London North West Healthcare NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fistula healing | 1 year | clinical and radiological healing |
Secondary
| Measure | Time frame |
|---|---|
| adverse effects or perioperative compilations related to device | within first year |
Countries
United Kingdom
Outcome results
None listed