Department of Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, The Netherlands.
BJOG. 2011 Dec;118(13):1568-75. doi: 10.1111/j.1471-0528.2011.03089.x. Epub 2011 Sep 6.
To compare the effects of LigaSure versus the conventional bipolar technique on operating time and blood loss during laparoscopic hysterectomy.
A randomised controlled trial.
Three teaching hospitals.
Women undergoing a laparoscopic hysterectomy for benign indications.
140 women undergoing a laparoscopic hysterectomy were randomised for LigaSure or conventional bipolar instruments.
Primary outcome was operating time from initial skin incision till detachment of the uterus. Secondary outcome measures were total operating time (from initial skin incision till final skin closure), time to dissect the adnexal ligaments, intra-operative blood loss and subjective evaluation by the surgeon of the instrument used.
No differences in operating time (from initial skin incision till uterine detachment and initial skin incision till final skin closure) using LigaSure versus conventional bipolar instruments: 97.6 versus 91.8 minutes (P = 0.39, 95% CI - 7.6 to 19.2), and 148.1 versus 142.1 minutes (P = 0.46, 95% CI - 10.1 to 22.3), respectively. The mean blood loss using LigaSure versus conventional bipolar was 234.1 versus 273.1 ml (P = 0.46, 95% CI -39.1 to 52.7). Various subjective efficacy and instrument handling parameters were significantly different between the two instruments and between the different participating centres. CONCLUSIONS There were no significant differences in operating time and blood loss between the use of LigaSure and the use of conventional bipolar instruments during laparoscopic hysterectomy, even after correction for potential confounders. User satisfaction parameters were assessed as significantly different by surgeons of the participating centres.
比较 LigaSure 与传统双极技术在腹腔镜子宫切除术中对手术时间和失血量的影响。
随机对照试验。
三所教学医院。
因良性指征接受腹腔镜子宫切除术的女性。
140 名因良性指征接受腹腔镜子宫切除术的女性被随机分为 LigaSure 或传统双极器械组。
主要结局指标为从初始皮肤切口到子宫分离的手术时间。次要结局指标为总手术时间（从初始皮肤切口到最终皮肤关闭）、附件韧带分离时间、术中失血量以及术者对所用器械的主观评价。
使用 LigaSure 与传统双极器械的手术时间（从初始皮肤切口到子宫分离和从初始皮肤切口到最终皮肤关闭）无差异：97.6 分钟与 91.8 分钟（P = 0.39，95%CI -7.6 至 19.2），148.1 分钟与 142.1 分钟（P = 0.46，95%CI -10.1 至 22.3）。使用 LigaSure 与传统双极器械的平均失血量分别为 234.1 毫升与 273.1 毫升（P = 0.46，95%CI -39.1 至 52.7）。两种器械之间以及不同参与中心之间，各种主观疗效和器械处理参数均有显著差异。结论：即使在校正潜在混杂因素后，LigaSure 与传统双极器械在腹腔镜子宫切除术中的手术时间和失血量无显著差异。术者评估的器械满意度参数存在显著差异。
