None listed
Conditions
Brief summary
Multiple surgical techniques have been described in the surgical literature for the treatment of high anal fistulas. High anal fistulas include a large proportion of the anal sphincter muscles and therefore, laying open these fistula tracts (which is the most effective way to treat a fistula) is not an option due to the high likelihood of faecal incontinence. The anal fistula plug is a technique used to induce fistula tract healing and closure by plugging the internal opening. This has gained popularity in the past 5 years. The Concord Hospital Colorectal Unit published the outcomes from anal fistula plugs in 2010 and reported a success rate of 35%. A new technique called Ligation of the Intersphincteric Fistula Tract or 'LIFT' was described in 2007 for treating high anal fistulas. This also aims to disrupt the fistula tract but does so by tying off the tract close to its internal opening without injury to the surrounding anal sphincter muscle mechanism. Success rates of this technique in published case series range between 54 to 94%, although followup and definitions of successful fistula closure varies between studies. Both techniques are simple procedures that involve no muscle division. The aim of this project is to assess and evaluate the rates of successful fistula closure comparing the two techniques of the anal fistula plug versus the 'LIFT' procedure. To allow effective comparison between techniques, we are conducting a randomised trial on patients with high anal fistulas at Concord Hospital.
Interventions
Ligation of intersphincteric fistula tract (LIFT):
A pre-operative questionnaire assessing symptoms of incontinence will be completed after recruitment into the study. Following a sodium phosphate enema given one hour pre-operatively, the LIFT procedure is performed in the lithotomy or prone position under general anaesthesia with intravenous administration of 500mg metronidazole for antibiotic prophylaxis. Preparation of the operative site with Betadine and draping is performed in the standard
Ligation of intersphincteric fistula tract (LIFT): A pre-operative questionnaire assessing symptoms of incontinence will be completed after recruitment into the study. Following a sodium phosphate enema given one hour pre-operatively, the LIFT procedure is performed in the lithotomy or prone position under general anaesthesia with intravenous administration of 500mg metronidazole for antibiotic prophylaxis. Preparation of the operative site with Betadine and draping is performed in the standard manner. The internal opening is visualised with an anal retractor by the injection of water or hydrogen peroxide solution via the external opening. The fistula tract is cannulated with a Lockhart-Mummery fistula probe, the seton removed and an incision made adjacent to the intersphincteric groove. The intersphincteric plane is entered with the diathermy blade and artery forceps. The external and internal anal sphincter muscles are retracted apart and the fistula tract is encircled in the intersphincteric plane. The fistula probe is removed and the tract is suture ligated with 2/0 polyglactin on both the internal sphincter side and external sphincter side and is subsequently divided. Confirmation of division and secure ligation is made by further injection of saline or peroxide via the external opening of the fistula tract. Limited excision of the external opening is then performed and is left open. The intersphincteric incision is closed with interrupted 3/0 polyglactin sutures. The approximate duration of the procedure will be 60 to 90 minutes. Oral ciprofloxacin 250mg twice daily and metronidazole 200mg every 8 hours are prescribed for 2 weeks
Sponsors
Concord Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with complex transphincteric anal fistula of cryptoglandular origin determined by examination under anaesthesia and endoanal ultrasography will be eligible for the study following the insertion of a seton into the fistula tract for a minimum of 6 weeks.
Exclusion criteria
1) Active anorectal or perianal sepsis 2) Anovaginal or rectovaginal fistulas 3) Ileo-anal pouch vaginal fistulas 4) Allergy or intolerance to porcine products 5) Ulcerative colitis or Crohn’s disease 6) Previous anal fistula plug, LIFT procedure, fistulotomy, lateral anal sphincterotomy and anal sphincter repair 7) Pregnancy at recruitment or parturition during study follow-up period 8) Patients deemed unable to give informed consent on clinical grounds
Outcome results
None listed