Pathfinder Fistula Probe System
Research type
Research Study
Full title
A prospective non-randomised study of the Pathfinder Fistula Probe System for treatment of perianal fistula
IRAS ID
159383
Contact name
Charles H Knowles
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN00031053
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
An anal fistula is an abnormal connection between the lining on the inside of the anal canal (back passage) and the skin near the anus. Most anal fistulae are caused by an abscess (a collection of pus) just outside the anal canal which then drains away onto the skin on its own or by an operation. A fistula happens when the track, made by the pus on the way to the surface of the skin, stays open. This leads to problems such as pain, persistent discharge and ultimately damage to the anal sphincter muscles. \n\nNearly all treatments for anal fistula involve surgery. Numerous operations exist to try and cure the fistula but these usually require division of some of the anal sphincter muscle with a subsequent risk of incontinence. Thus ‘high’ fistulae (denoting those which cross a lot of muscle) cannot be safely cured and instead symptoms may be controlled by insertion of a special ‘stitch’ called a seton which runs through the cleaned fistula track and allows chronic but controlled drainage preventing further damage from infection and abscess formation. \n\nThe current methods to place a seton at operation use a variety of metal sterilised probes that are broadly unchanged since the 1920s. These are still effective in most circumstances but occasionally pose difficulties for the surgeon, particularly in ‘high’ fistulae. Thus there is considerable room for improvement.\n\nThe current proposal aims to assess the safety and usability of our newly designed surgical instrument, the Pathfinder Fistula Probe System, to be used intraoperatively.\n
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1765
Date of REC Opinion
6 Jan 2016
REC opinion
Further Information Favourable Opinion