Randomised controlled trial comparing cutting seton vs ligation of intersphincteric fistula tract (LIFT) for complex anal fistula

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Anal fistula is a common condition. The aims of treatment are fistula healing, prevention of recurrence and maintenance of continence. Treatment options and their associated risks vary according to the fistula track. Simple fistulae (intersphincteric or low trans-sphincteric) may be treated successfully with fistulotomy. Complex fistulae pose a therapeutic challenge and carry a higher risk of treatment failure, altered continence and recurrence. (Joy and Williams 2002) (van okelen, Gosselink et al. 2013) To date, no single intervention simultaneously fulfils all three therapeutic aims. The cutting seton has been employed for centuries and involves the use of various materials (including suture, vessel loops etc) to slowly divide through the sphincter and induce fibrosis. The literature reports recurrence rates in the 3 – 5 % range (Vial, Pares et al. 2010) . Reported incontinence rates after cutting seton vary widely from 0 - 63 % (Vial, Pares et al. 2010) (Garcia-Aguilar, Belmonte et al. 1998) (Karri-Pekka, Hamalainen et al. 1997) (Charua-Guindic, Mendez-Moran et al. 2007) (Ritchie, Sackier et al. 2008) , which may be partially attributable to incomplete/inadequate scarring behind the seton when tightened rapidly. The ligation of the intersphincteric track (LIFT) procedure was described in 2007 as a sphincter preserving technique for high fistulae. (Rojanasakul, Pattanaarun et al. 2007) Early reports published fistula cure and continence rates in excess of 90% (ref). Subsequent series have reported success rates ranging from 57% to 82%. (Yassin, Hammond et al. 2013) The procedure involves identification, dissection and then ligation of the fistula track in the intersphincteric space, thereby eliminating the fistula source from its track and avoiding the need for sphincter division. Multiple interventions to manage fistulae have been described including sphincter preserving techniques such as fibrin plugs and tissue glue. (Ellis and Clark 2006) (Garg 2009) With the prospect of altered continence as a complication, heterogeneity of fistula anatomy, and the interplay with physiology, studies are limited in their ability to generalise findings and recommend treatments in the form of guidelines. Aim To prospectively assess the clinical outcomes of patients with complex fistulae treated by cutting seton and compare these to patients treated by LIFT.

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