An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes

Abstract

Background For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes. Methods MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed. Results Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes. Conclusion Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

Safety and effectiveness of using Disposable Ultrasonic Shears to coagulate 5-7mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial

“…With the accumulation of experience in use and the deepening of studies, the scope of application of the ultrasonic scalpel has been gradually expanded to the resection of stomach, intestine, liver, pancreas, spleen, kidneys, lungs, and pelvic viscera. The ultrasonic scalpel can be used to reduce bleeding, improve the e cacy of surgeries, and reduce the incidence of complications [4,5].…”