Comparison of LigaSure™ tissue fusion system and a conventional bipolar device in hysterectomy via natural orifice transluminal endoscopic surgery (NOTES): A randomized controlled trial

Abstract

Objective: To evaluate the efficacy and effectiveness of applying LigaSure™ Tissue Fusion System in hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES) in comparison with using the conventional bipolar device. Materials and methods: Eighty women scheduled for hysterectomy by transvaginal NOTES were prospectively randomized into applying LigaSure (study group) or conventional bipolar instrument (control group) in an intention-to-treat analysis. Primary endpoints were the device-related efficacy; secondary endpoints were surgical effectiveness measured by operative time, blood loss, postoperative pain and adverse events. Results: In the eligibly allocated patients, three in the control group (n = 39) converted to applying LigaSure and one converted to conventional laparoscopy intraoperatively, while none in the LigaSure group (n = 38) found such conversions. Patients who completed full analysis in the LigaSure (n = 36) and control (n = 35) groups did not differ significantly in operative time, estimated blood loss, and the length of hospital stay. In the subgroup of women who underwent hysterectomy only, the LigaSure group (n = 22) showed significantly reduced operative time than the control group (76.50 ± 24.74 min versus 93.96 ± 27.10 min, p = 0.029). Postoperative pain scores were statistically higher in the LigaSure group within 36 h; however, the difference was not clinically significant. The incidence of postoperative adverse events between the groups was not different; nevertheless, device-related adverse events was not found in the LigaSure group. Conclusion: LigaSure™ tissue fusion technology was feasible and efficacious without compromising surgical procedures for hysterectomy by transvaginal NOTES compared with the conventional bipolar hemostasis device. Keywords: Hysterectomy, Transvaginal, Natural orifice transluminal endoscopic surgery, Ligasure, Operating time