Jayne DG, Scholefield J, Tolan D, et al. - In this study, a randomized comparison of the Biodesign Surgisis anal fistula plug was performed against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. Randomization of 304 participants was done to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). At 12 months, faecal incontinence quality of life and healing rates achieved in correlation with the Biodesign Surgisis anal fistula plug were similar to those observed with surgeon's preference. The fistula plug may not be considered as a cost-effective treatment in the UK NHS owing to the higher costs and highly uncertain gains in QALYs.