Comparison of the efficacy of venous coupler and hand-sewn anastomosis in maxillofacial reconstruction using microvascular fibula free flaps: a prospective randomized controlled trial.

The venous coupler has emerged as a suitable alternative to hand suturing in the microvascular anastomosis of blood vessels; however, no prospective comparative studies have been performed to date. The aim of this study was to prospectively compare the efficacy of venous anastomosis using a coupler device with hand-sewn anastomosis during reconstruction surgery for maxillofacial defects. A prospective, randomized controlled trial was conducted. Group A patients (n=60) underwent microvascular anastomosis using a venous coupler and group B patients (n=64) with conventional sutures. The primary outcome measure was the incidence of flap thrombosis. Secondary measures included the flap outcome. The mean time taken to complete the anastomosis was 7.9min in group A and 18.5min in group B; this difference was statistically significant. The incidence of venous thrombosis was 1.7% in group A and 7.8% in group B; this difference was not statistically significant. While the time taken to complete the anastomosis is shortened using the coupler device, the clinical outcome remains the same with both techniques. The two techniques would work equally well in the hands of an experienced surgeon, and the cost versus benefit must be determined for each patient.

RCT Entities:   Population Interventions Outcomes