Evaluation of a novel powered vascular stapler in laparoscopic nephrectomy

Abstract

Objective: The purpose of this study was to determine if use of a powered vascular stapler (PVS) during laparoscopic nephrectomy or nephroureterectomy procedures would yield an equivalent rate of additional hemostatic interventions to Standard of Care (SOC) staplers. Methods: A prospective, randomized, multicentre, controlled study was conducted comparing the use of PVS to SOC in laparoscopic nephrectomy or nephroureterectomy. The primary performance endpoint was the incidence of additional intraoperative haemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions. Equivalence was denoted by a 95% confidence interval for the difference in intervention rates between PVC and SOC with a limitation of 3%. Results: There were 136 subjects in the SOC group and 130 subjects in the PVS group who completed the study. The rates of intraoperative haemostatic interventions were 13.6% and 18.4% for SOC and PVS groups, respectively, (p=0.107). The upper bound of the difference in intervention rates exceeded the 3% criterion for equivalence. Postoperative bleeding that required intervention was experienced in two subjects (1.4%) in the SOC group and one (0.8%) in PVS. There were four adverse events rated as serious for SOC and none for PVS. Estimated blood loss was similar between the two groups. Conclusions: The PVS performed safely and effectively in nephrectomy and exhibited a rate of haemostatic intervention that was not statistically different than the SOC.