PURPOSE: LigaSure, a bipolar electronic vessel sealing system, has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer. METHODS: In this multicenter, prospective, randomized controlled trial, patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with LigaSure or a conventional technique. RESULTS: Of the 160 patients enrolled, 80 were randomized to the LigaSure group and 78 to the conventional group. Patient characteristics were well balanced in the two groups. There were no significant differences between the LigaSure and conventional groups in blood loss (288 vs. 260 ml, respectively; P = 0.748) or operative time (223 and 225 min, respectively; P = 0.368); nor in the incidence of surgical complications or duration of postoperative hospital stay. In a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum, the use of LigaSure significantly reduced blood loss (179 vs. 245 ml; P = 0.033), and the duration of the operation (195 vs. 221 min; P = 0.039). CONCLUSIONS: LigaSure did not contribute to reducing intraoperative blood loss, operative time, or other adverse surgical outcomes. The usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy.
RCT Entities:
PURPOSE: LigaSure, a bipolar electronic vessel sealing system, has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer. METHODS: In this multicenter, prospective, randomized controlled trial, patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with LigaSure or a conventional technique. RESULTS: Of the 160 patients enrolled, 80 were randomized to the LigaSure group and 78 to the conventional group. Patient characteristics were well balanced in the two groups. There were no significant differences between the LigaSure and conventional groups in blood loss (288 vs. 260 ml, respectively; P = 0.748) or operative time (223 and 225 min, respectively; P = 0.368); nor in the incidence of surgical complications or duration of postoperative hospital stay. In a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum, the use of LigaSure significantly reduced blood loss (179 vs. 245 ml; P = 0.033), and the duration of the operation (195 vs. 221 min; P = 0.039). CONCLUSIONS: LigaSure did not contribute to reducing intraoperative blood loss, operative time, or other adverse surgical outcomes. The usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy.