Fibrin glue as an adjunct to flap repair of anal fistulas: A randomized, controlled study

PURPOSE: Both flap repair and fibrin glue are accepted sphincter-preserving techniques for managing anal fistulas. Additionally, the two techniques are not mutually exclusive and can be combined. This trial was undertaken to determine whether the combination of flap repair and fibrin glue resulted in better outcomes than flap repair alone. METHODS: Between July 2000 and March 2004, patients with transsphincteric anal fistulas were randomly assigned to advancement flap repair alone or flap repair combined with fibrin glue obliteration of the fistula tract. Data regarding age, gender, fistula anatomy, race, and previous repairs were collected. Fistulas managed by fistulotomy or caused by Crohn's disease, acute obstetric trauma, or radiation were excluded from this study. RESULTS: There were 58 patients randomized to flap repair alone or flap repair with fibrin glue (47 males; median age, 47 (range, 29-68) years). Mucosal advancement flap was performed in 36 patients and anodermal advancement flap was performed in 22. The median follow-up was 22 (range, 12-36) months. Total fistula recurrence rate for all patients was 32.6 percent. The recurrence rate for fistulas repaired by advancement flap alone was 20 percent, whereas the recurrence rate for fistulas repaired by advancement flap with fibrin glue was 46.4 percent (P <;0.05). CONCLUSIONS: The data fail to show improved outcomes when fibrin sealant is used in combination with an advancement flap compared with advancement flap alone for the management of complex anal fistulas.