Sandberg Evelien M, la Chapelle Claire F, van den Tweel Marjolein M, Schoones Jan W, Jansen Frank Willem
Department of Gynecology, Minimally Invasive Surgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Walaeus Library, Leiden University Medical Center, Leiden, The Netherlands.
Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
To assess the safety and effectiveness of LESS compared to conventional hysterectomy.
The systematic review and meta-analysis was performed according to the MOOSE guideline, and quality of evidence was assessed using GRADE. Different databases were searched up to 4th of August 2016. Randomized controlled trials and cohort studies comparing LESS to the conventional laparoscopic hysterectomy were considered for inclusion.
Of the 668 unique articles, 23 were found relevant. We investigated safety by analyzing the complication rate and found no significant differences between both groups [OR 0.94 (0.61, 1.44), I = 19%]. We assessed effectiveness by analyzing conversion risk, postoperative pain, and patient satisfaction. For conversion rates to laparotomy, no differences were identified [OR 1.60 (0.40, 6.38), I = 45%]. In 3.5% of the cases in the LESS group, an additional port was needed during LESS. For postoperative pain scores and patient satisfaction, some of the included studies reported favorable results for LESS, but the clinical relevance was non-significant. Concerning secondary outcomes, only a difference in operative time was found in favor of the conventional group [MD 11.3 min (5.45-17.17), I = 89%]. The quality of evidence for our primary outcomes was low or very low due to the study designs and lack of power for the specified outcomes. Therefore, caution is urged when interpreting the results.
The single-port technique for benign hysterectomy is feasible, safe, and equally effective compared to the conventional technique. No clinically relevant advantages were identified, and as no data on cost effectiveness are available, there are currently not enough valid arguments to broadly implement LESS for hysterectomy.
评估单孔腹腔镜手术(LESS)相较于传统子宫切除术的安全性和有效性。
按照MOOSE指南进行系统评价和荟萃分析,并使用GRADE评估证据质量。检索了截至2016年8月4日的不同数据库。纳入比较LESS与传统腹腔镜子宫切除术的随机对照试验和队列研究。
在668篇独立文章中,发现23篇相关。我们通过分析并发症发生率来研究安全性,发现两组之间无显著差异[比值比(OR)0.94(0.61,1.44),I² = 19%]。我们通过分析中转开腹风险、术后疼痛和患者满意度来评估有效性。对于中转开腹率,未发现差异[OR 1.60(0.40,6.38),I² = 45%]。在LESS组3.5%的病例中,LESS手术期间需要额外增加一个端口。对于术后疼痛评分和患者满意度,部分纳入研究报告LESS有较好结果,但临床相关性不显著。关于次要结局,仅发现手术时间存在差异,传统组更具优势[平均差(MD)11.3分钟(5.45 - 17.17),I² = 89%]。由于研究设计和特定结局的检验效能不足,我们主要结局的证据质量为低或极低。因此,在解释结果时应谨慎。
与传统技术相比,单孔腹腔镜良性子宫切除术技术可行、安全且同样有效。未发现临床相关优势,且由于缺乏成本效益数据,目前尚无足够有效论据广泛应用LESS进行子宫切除术。