Bhave Chittawar Priya, Franik Sebastian, Pouwer Annefloor W, Farquhar Cindy
Department of Reproductive Medicine, Bansal Hospital, C Sector Shahpura, Bhopal, Madhya Pradesh, India, 462016.
Cochrane Database Syst Rev. 2014 Oct 21;2014(10):CD004638. doi: 10.1002/14651858.CD004638.pub3.
Fibroids are common benign tumours arising in the uterus. Myomectomy is the surgical treatment of choice for women with symptomatic fibroids who prefer or want uterine conservation. Myomectomy can be performed by conventional laparotomy, by mini-laparotomy or by minimal access techniques such as hysteroscopy and laparoscopy.
To determine the benefits and harms of laparoscopic or hysteroscopic myomectomy compared with open myomectomy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (inception to July 2014), the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of Controlled Trials (inception to July 2014), MEDLINE(R) (inception to July 2014), EMBASE (inception to July 2014), PsycINFO (inception to July 2014) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (inception to July 2014) to identify relevant randomised controlled trials (RCTs). We also searched trial registers and references from selected relevant trials and review articles. We applied no language restriction in these searches.
All published and unpublished randomised controlled trials comparing myomectomy via laparotomy, mini-laparotomy or laparoscopically assisted mini-laparotomy versus laparoscopy or hysteroscopy in premenopausal women with uterine fibroids diagnosed by clinical and ultrasound examination were included in the meta-analysis.
We conducted study selection and extracted data in duplicate. Primary outcomes were postoperative pain, reported in six studies, and in-hospital adverse events, reported in eight studies. Secondary outcomes included length of hospital stay, reported in four studies, operating time, reported in eight studies and recurrence of fibroids, reported in three studies. Each of the other secondary outcomes-improvement in menstrual symptoms, change in quality of life, repeat myomectomy and hysterectomy at a later date-was reported in a single study. Odds ratios (ORs), mean differences (MDs) and 95% confidence intervals (CIs) were calculated and data combined using the fixed-effect model. The quality of evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods.
We found 23 potentially relevant trials, of which nine were eligible for inclusion in this review. The nine trials included in our meta-analysis had a total of 808 women. The overall risk of bias of included studies was low, as most studies properly reported their methods.Postoperative pain: Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Postoperative pain was significantly less, as determined by subjectively assessed pain score at six hours (MD -2.40, 95% CI -2.88 to -1.92, one study, 148 women, moderate-quality evidence) and 48 hours postoperatively (MD -1.90, 95% CI -2.80 to -1.00, two studies, 80 women, I² = 0%, moderate-quality evidence) in the laparoscopic myomectomy group compared with the open myomectomy group. This means that among women undergoing laparoscopic myomectomy, mean pain score at six hours and 48 hours would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. No significant difference in postoperative pain score was noted between the laparoscopic and open myomectomy groups at 24 hours (MD -0.29, 95% CI -0.7 to 0.12, four studies, 232 women, I² = 43%, moderate-quality evidence). The overall quality of these findings is moderate; therefore further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.In-hospital adverse events: No evidence suggested a difference in unscheduled return to theatre (OR 3.04, 95% CI 0.12 to 75.86, two studies, 188 women, I² = 0%, low-quality evidence) and laparoconversion (OR 1.11, 95% CI 0.44 to 2.83, eight studies, 756 women, I² = 53%, moderate-quality evidence) when open myomectomy was compared with laparoscopic myomectomy. Only one study including 148 women reported injury to pelvic organs (no events were described in other studies), and no significant difference was noted between laparoscopic myomectomy and laparoscopically assisted mini-laparotomy myomectomy (OR 3.04, 95% CI 0.12 to 75.86). Significantly lower risk of postoperative fever was observed in the laparoscopic myomectomy group compared with groups treated with all types of open myomectomy (OR 0.44, 95% CI 0.26 to 0.77, I² = 0%, six studies, 635 women). This indicates that among women undergoing laparoscopic myomectomy, the risk of postoperative fever is 50% lower than among those treated with open surgery. No studies reported immediate hysterectomy, uterine rupture, thromboembolism or mortality. Six studies including 549 women reported haemoglobin drop, but these studies were not pooled because of extreme heterogeneity (I² = 97%) and therefore could not be included in the analysis.
AUTHORS' CONCLUSIONS: Laparoscopic myomectomy is a procedure associated with less subjectively reported postoperative pain, lower postoperative fever and shorter hospital stay compared with all types of open myomectomy. No evidence suggested a difference in recurrence risk between laparoscopic and open myomectomy. More studies are needed to assess rates of uterine rupture, occurrence of thromboembolism, need for repeat myomectomy and hysterectomy at a later stage.
子宫肌瘤是子宫常见的良性肿瘤。对于有症状且希望保留子宫的子宫肌瘤女性患者,肌瘤切除术是首选的手术治疗方式。肌瘤切除术可通过传统剖腹术、小切口剖腹术或诸如宫腔镜检查和腹腔镜检查等微创手术来进行。
确定与开放性肌瘤切除术相比,腹腔镜或宫腔镜肌瘤切除术的益处和危害。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(建库至2014年7月)、月经紊乱与生育力低下组(MDSG)对照试验专门注册库(建库至2014年7月)、医学期刊数据库(MEDLINE)(建库至2014年7月)、荷兰医学文摘数据库(EMBASE)(建库至2014年7月)、心理学文摘数据库(PsycINFO)(建库至2014年7月)以及护理学与健康相关文献累积索引数据库(CINAHL)(建库至2014年7月),以识别相关的随机对照试验(RCT)。我们还检索了试验注册库以及所选相关试验和综述文章的参考文献。这些检索未设语言限制。
所有已发表和未发表的随机对照试验,若比较经临床和超声检查诊断为子宫肌瘤的绝经前女性通过剖腹术、小切口剖腹术或腹腔镜辅助小切口剖腹术进行肌瘤切除术与腹腔镜或宫腔镜肌瘤切除术的效果,均纳入荟萃分析。
我们进行了重复的研究选择和数据提取。主要结局包括六项研究中报告的术后疼痛以及八项研究中报告的住院不良事件。次要结局包括四项研究中报告的住院时间、八项研究中报告的手术时间以及三项研究中报告的肌瘤复发情况。其他次要结局——月经症状改善、生活质量变化、后期再次肌瘤切除术和子宫切除术——每项均仅在一项研究中报告。计算比值比(OR)、均值差(MD)和95%置信区间(CI),并使用固定效应模型合并数据。采用推荐分级、评估、制定与评价(GRADE)方法评估证据质量。
我们发现23项可能相关的试验,其中9项符合纳入本综述的条件。我们荟萃分析纳入的9项试验共有808名女性。纳入研究的总体偏倚风险较低,因为大多数研究正确报告了其方法。
术后疼痛采用视觉模拟评分法(VAS)测量,0分表示“完全无痛”,10分表示“疼痛至极”。与开放性肌瘤切除术组相比,腹腔镜肌瘤切除术组术后6小时(MD -2.40,95%CI -2.88至-1.92,一项研究,148名女性,中等质量证据)和术后48小时(MD -1.90,95%CI -2.80至-1.00,两项研究,80名女性,I² = 0%,中等质量证据)主观评估的疼痛评分显示术后疼痛明显减轻。这意味着在接受腹腔镜肌瘤切除术的女性中,术后6小时和48小时的平均疼痛评分在VAS 0至10分的量表上可能比开放性肌瘤切除术组低约3分至1分。腹腔镜和开放性肌瘤切除术组在术后24小时的疼痛评分无显著差异(MD -0.29,95%CI -0.7至0.12,四项研究,232名女性,I² = 43%,中等质量证据)。这些结果的总体质量为中等;因此,进一步的研究可能会对我们对效应估计的信心产生重要影响,并可能改变估计值。
与腹腔镜肌瘤切除术相比,未发现开放性肌瘤切除术在非计划重返手术室(OR 3.04,95%CI 0.12至75.86,两项研究,188名女性,I² = 0%,低质量证据)和中转开腹(OR 1.11,95%CI 0.44至2.83,八项研究,756名女性,I² = 53%,中等质量证据)方面存在差异。仅有一项纳入148名女性的研究报告了盆腔器官损伤(其他研究未描述此类事件),且腹腔镜肌瘤切除术与腹腔镜辅助小切口剖腹肌瘤切除术之间未发现显著差异(OR 3.04,95%CI 0.12至75.86)。与所有类型的开放性肌瘤切除术组相比,腹腔镜肌瘤切除术组术后发热风险显著降低(OR 0.44,95%CI 0.26至0.77,I² = 0%,六项研究,635名女性)。这表明在接受腹腔镜肌瘤切除术的女性中,术后发热风险比接受开放手术的女性低50%。没有研究报告即时子宫切除术、子宫破裂、血栓栓塞或死亡情况。六项纳入549名女性的研究报告了血红蛋白下降,但由于极端异质性(I² = 97%),这些研究未进行汇总,因此未纳入分析。
与所有类型的开放性肌瘤切除术相比,腹腔镜肌瘤切除术术后主观报告的疼痛较少、术后发热较低且住院时间较短。没有证据表明腹腔镜和开放性肌瘤切除术在复发风险上存在差异。需要更多研究来评估子宫破裂发生率、血栓栓塞的发生情况、后期再次肌瘤切除术和子宫切除术的需求。