FIX-IT 1 Study
Research type
Research Study
Full title
Feasibility study to assess the early use of porcine cross-linked collagen paste in cryptoglandular anal fistulas (FIX-IT 1 Study)
IRAS ID
172391
Contact name
Neil Smart
Contact email
Sponsor organisation
Royal Devon and Exeter NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
An anorectal abscess is a collection of pus in the anal and rectal region. These abscesses present as painful hard lumps in or around the back passage associated with pus discharge, tenderness and fever. Up to half of the abscesses are associated with an underlying fistula. A fistula-in-ano is an abnormal tract or cavity with an external opening in the perianal area that is communicating with the rectum or anal canal by an identifiable internal opening. Occasionally, bacteria, faecal material or foreign matter can clog the anal gland and create a condition for an abscess cavity to form.
Anorectal abscess can be easily diagnosed with physical examination of anus and rectum. An underlying fistula generally requires an MRI scan and examination under general anesthetic to delineate the anatomy accurately. Most anal fistulas require surgery because they rarely heal if they are not treated. Several surgical methods are available depending on where the fistula is and if it is classed as simple or complex. There is a risk of complication from anal fistula surgery including bowel incontinence, infection and fistula coming back. Often patients will require several operations to treat the fistula.
This pilot study is designed to evaluate the use of connective tissue paste derived from pig skin to occlude the fistula tract in the early stages of the disease process and if this will promote early healing of fistulas. There is limited evidence behind the use of pig skin collagen but early evidence suggests this may be appropriate and further studies are required. If successful then we would hope this will reduce the chance of patients requiring further operations.
REC name
South West - Frenchay Research Ethics Committee
REC reference
15/SW/0167
Date of REC Opinion
8 Sep 2015
REC opinion
Further Information Favourable Opinion