A randomized phase II study of the clinical effects of ultrasonically activated coagulating shears (Harmonic scalpel) in open gastrectomy for gastric cancer

Purpose The Harmonic Ace ultrasonic scalpel has been popular in abdominal surgery; however, only a few clinical studies have evaluated the efficacy of this device in radical open gastrectomy for gastric cancer. Methods The present study was designed as a multicenter, prospective, randomized, controlled trial. Patients with resectable gastric cancer were randomly assigned to gastrectomy using the Harmonic scalpel or conventional monopolar electrosurgery. Results A total of 248 patients were enrolled, and 123 patients were included in the Harmonic group and 114 patients were included in the conventional group. The demographics of the patients were well balanced between the groups. There was no significant difference in the length of the operation from skin incision to resection of the gastric specimen (141 ± 36 min in the Harmonic group vs. 147 ± 13 min in the conventional group; p = 0.276) nor in the amount of blood lost (365 ± 293 vs. 336 ± 272 mL; p = 0.434). There was also no significant difference in the incidence of surgical complications or the post-surgical hospital stay between the groups. Conclusion The Harmonic scalpel procedure was not superior to the conventional monopolar electrosurgery with regard to reducing the length of the operation, blood loss, postoperative complications, or postoperative hospital stay in radical open gastrectomy.