Abstract

Anal fistula is an abnormal connection between the anal or rectal lumen and perianal skin that reduce quality of life. There are various surgical options for treatment with variable success rate. A novel treatment is to seal the fistula tract using biomaterials (fibrin glue and fibrin plug). Objective of this study was to evaluate the healing efficacy and incontinence rate of biomaterials (fibrin glue and fibrin plug) in comparison to surgical interventions in the treatment of cryptoglandular perianal fistula using meta-analysis of randomized controlled trials. PubMed, Scopus, Google Scholar and Web of Science were searched for clinical trial studies investigated the effects of biomaterials in the treatment of fistula-in-ano. Studies on patient with anal fistulae underwent fibrin glue, fibrin plug or other biomaterials application and surgical management for healing of fistula were included. Clinical response and incontinence were the key outcomes of interest. Six randomized placebo-controlled clinical trials consisting 315 patients in various arms met our criteria (comparing biomaterial with surgical interventions) and were included in the analysis. Pooling of data showed that effectiveness of biomaterials in comparison to surgical interventions was non-significant with relative risk (RR) of 0.73 (95% CI of 0.31-0.89, p = 0.096). The incontinence rate RR in biomaterials and intervention was also non significant with RR of 0.35 (95% CI = 0.05-2.28, p = 0.27). The included clinical trials had different follow-up durations, causes of fistula and method of intervention in treated patients. This meta-analysis demonstrates that the effectiveness and incontinence rate of biomaterials and conservative treatment is not significantly different.