Ligation of Intersphincteric Fistula Tract (LIFT) with or Without Injection of Bone Marrow Mononuclear Cells in the Treatment of Trans-sphincteric Anal Fistula: a Randomized Controlled Trial

Abstract

BackgroundLigation of intersphincteric fistula tract (LIFT) is a sphincter-saving procedure used for treatment of complex anal fistula. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate. MethodsThis was a prospective randomized trial on patients with trans-sphincteric anal fistula. Patients were randomly allocated to one of two equal groups: LIFT and LIFT with BM-MNC injection. The main outcome measures were healing at 10 weeks of follow-up, recurrence after healing, and complications. ResultsSeventy patients (48 male and 22 female) of a mean age of 37.9±10.4 years were included. The mean time to complete healing after LIFT + BM-MNCs was significantly shorter than after LIFT alone (20.5±5.2 vs 28.04±5.8 days; P < 0.0001). The ultimate success rates of both groups were similar (LIFT = 60% vs LIFT with BM-MNCs = 68.6%, P = 0.62). There was no significant difference in the mean operation time or complication rate between the two groups. Secondary extension and previous anal surgery were significant independent predictors of failure of healing. ConclusionLIFT combined with BM-MNC injection was associated with a shorter time to complete healing than LIFT alone. However, BM-MNC injection did not have a significant impact on the overall healing and ultimate success rate.