Lee Chyi-Long, Wu Kai-Yun, Huang Chen-Ying, Yen Chih-Feng
Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, Taiwan; Department of Obstetrics and Gynecology, Chang Gung University College of Medicine, Taiwan.
Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, Taiwan; Department of Obstetrics and Gynecology, Chang Gung University College of Medicine, Taiwan.
Taiwan J Obstet Gynecol. 2019 Jan;58(1):128-132. doi: 10.1016/j.tjog.2018.11.024.
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.
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.
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.
LigaSure™ tissue fusion technology was feasible and efficacious without compromising surgical procedures for hysterectomy by transvaginal NOTES compared with the conventional bipolar hemostasis device.
评估与使用传统双极设备相比，LigaSure™组织融合系统在经阴道自然腔道内镜手术（NOTES）子宫切除术中的有效性和效能。
80例计划行经阴道NOTES子宫切除术的女性被前瞻性随机分为使用LigaSure组（研究组）或传统双极器械组（对照组），进行意向性分析。主要终点是与设备相关的有效性；次要终点是通过手术时间、失血量、术后疼痛和不良事件衡量的手术效能。
在符合分配条件的患者中，对照组（n = 39）有3例术中转为使用LigaSure，1例转为传统腹腔镜手术，而LigaSure组（n = 38）无此类转换情况。在LigaSure组（n = 36）和对照组（n = 35）中完成全面分析的患者在手术时间、估计失血量和住院时间方面无显著差异。在仅接受子宫切除术的女性亚组中，LigaSure组（n = 22）的手术时间明显短于对照组（76.50 ± 24.74分钟对93.96 ± 27.10分钟，p = 0.029）。LigaSure组术后36小时内的疼痛评分在统计学上较高；然而，差异在临床上不显著。两组术后不良事件的发生率无差异；尽管如此，LigaSure组未发现与设备相关的不良事件。
与传统双极止血设备相比，LigaSure™组织融合技术在经阴道NOTES子宫切除术中可行且有效，同时不影响手术操作。
