Aim: To evaluate the convenience in terms of recurrence and fecal incontinence rates of fibrin glue versus surgical treatment in the management of fistula-in-ano.
Materials and methods: Randomized controlled trials (RCTs) and non-randomized studies (CCTs) comparing conventional surgical treatment versus fibrin glue treatment in patients with perianal fistulae were identified using a predefined search strategy. The post treatment anal incontinence rate and the fistula recurrence rates between the two operations were compared by using the methods provided by the Cochrane Handbook for Systematic Reviews of Interventions. The lack of homogeneity of results between the different studies did not allow to analyze other secondary outcomes. Patients with cryptoglandular and Crohn's anal fistula were enrolled in the analysis. The employed fibrin glue came from commercial kits: Beriplast (Aventis Behring, Sussex, United Kingdom) and Tisseal or Tissucol (Baxter, Inc, Mississauga, Ontario). Surgical conventional treatment consisted of fistulotomy, placement of a cutting or loose latex seton and advancement mucosal flap closure. All patients were followed up at 6 and 12 weeks, the longest follow up was 6 months.
Results: Two RCTs (106 patients) and 1 non randomized studies (232 patients) were identified. The recurrence rate is higher, although still not statistically significant, in those patients who underwent fibrin glue injection (44/81) versus conventional surgical treatment (108/230), (OR: 0.44; 95 %CI: 0.12-1.68; P = 0.23). Furthermore in the analysis of the subgroup of RCTs alone there were not significant differences with the previous results of RCTs with CCT analysis (OR: 0.33; 95 %CI: 0.03-3.66; P = 0.37). In the same way the analysis of the subgroup of RCTs with complex anal fistulae were not statistically significant and similar to the previous results regarding all type of fistulas (OR: 0.86; 95 %CI: 0.01-72.36; P = 0.95). The analysis of post-operative anal incontinence showed no difference between the group who underwent fibrin glue injection (9/230) and the conventional surgical treatment group (10/81), (OR: 1.00; 95 %CI: 0.43-2.34; P = 1.00). A very low heterogeneity in the analysis was detected (Chi-square = 0.04 - P = 0%).
Conclusion: Our statistical analysis does not show any significant statistical difference between fibrin glue treatment versus conventional surgical treatment for all perianal fistulae in terms of recurrence (P = 0.23) and anal incontinence (P = 1.00).