Metwally Mostafa, Raybould Grace, Cheong Ying C, Horne Andrew W
Sheffield Teaching Hospitals, The Jessop Wing and Royal Hallamshire Hospital, Sheffield, UK, S10 2JF.
University of Sheffield, Department of Oncology & Metabolism, Academic Unit of Reproductive and Developmental Medicine, Sheffield, UK.
Cochrane Database Syst Rev. 2020 Jan 29;1(1):CD003857. doi: 10.1002/14651858.CD003857.pub4.
Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.
To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.
We searched the Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Epistemonikos database, World Health Organization (WHO) International Clinical Trials Registry Platform search portal, Database of Abstracts of Reviews of Effects (DARE), LILACS, conference abstracts on the ISI Web of Knowledge, OpenSigle for grey literature from Europe, and reference list of relevant papers. The final search was in February 2019.
Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.
Data collection and analysis were conducted in accordance with the procedure suggested in the Cochrane Handbook for Systematic Reviews of Interventions.
This review included four RCTs with 442 participants. The evidence was very low-quality with the main limitations being due to serious imprecision, inconsistency and indirectness. Myomectomy versus no intervention One study examined the effect of myomectomy compared to no intervention on reproductive outcomes. We are uncertain whether myomectomy improves clinical pregnancy rate for intramural (odds ratio (OR) 1.88, 95% confidence interval (CI) 0.57 to 6.14; 45 participants; one study; very low-quality evidence), submucous (OR 2.04, 95% CI 0.62 to 6.66; 52 participants; one study; very low-quality evidence), intramural/subserous (OR 2.00, 95% CI 0.40 to 10.09; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 3.24, 95% CI 0.72 to 14.57; 42 participants; one study; very low-quality evidence). Similarly, we are uncertain whether myomectomy reduces miscarriage rate for intramural fibroids (OR 1.33, 95% CI 0.26 to 6.78; 45 participants; one study; very low-quality evidence), submucous fibroids (OR 1.27, 95% CI 0.27 to 5.97; 52 participants; one study; very low-quality evidence), intramural/subserous fibroids (OR 0.80, 95% CI 0.10 to 6.54; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 2.00, 95% CI 0.32 to 12.33; 42 participants; one study; very low-quality evidence). This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate. Laparoscopic myomectomy versus myomectomy by laparotomy or mini-laparotomy Two studies compared laparoscopic myomectomy to myomectomy at laparotomy or mini-laparotomy. We are uncertain whether laparoscopic myomectomy compared to laparotomy or mini-laparotomy improves live birth rate (OR 0.80, 95% CI 0.42 to 1.50; 177 participants; two studies; I = 0%; very low-quality evidence), preterm delivery rate (OR 0.70, 95% CI 0.11 to 4.29; participants = 177; two studies; I = 0%, very low-quality evidence), clinical pregnancy rate (OR 0.96, 95% CI 0.52 to 1.78; 177 participants; two studies; I = 0%, very low-quality evidence), ongoing pregnancy rate (OR 1.61, 95% CI 0.26 to 10.04; 115 participants; one study; very low-quality evidence), miscarriage rate (OR 1.25, 95% CI 0.40 to 3.89; participants = 177; two studies; I = 0%, very low-quality evidence), or caesarean section rate (OR 0.69, 95% CI 0.34 to 1.39; participants = 177; two studies; I = 21%, very low-quality evidence). Monopolar resectoscope versus bipolar resectoscope One study evaluated the use of two electrosurgical systems during hysteroscopic myomectomy. We are uncertain whether bipolar resectoscope use compared to monopolar resectoscope use improves live birth/ongoing pregnancy rate (OR 0.86, 95% CI 0.30 to 2.50; 68 participants; one study, very low-quality evidence), clinical pregnancy rate (OR 0.88, 95% CI 0.33 to 2.36; 68 participants; one study; very low-quality evidence), or miscarriage rate (OR 1.00, 95% CI 0.19 to 5.34; participants = 68; one study; very low-quality evidence). This study did not report on preterm delivery or caesarean section rate.
AUTHORS' CONCLUSIONS: There is limited evidence to determine the role of myomectomy for infertility in women with fibroids as only one trial compared myomectomy with no myomectomy. If the decision is made to have a myomectomy, the current evidence does not indicate a superior method (laparoscopy, laparotomy or different electrosurgical systems) to improve rates of live birth, preterm delivery, clinical pregnancy, ongoing pregnancy, miscarriage, or caesarean section. Furthermore, the existing evidence needs to be viewed with caution due to the small number of events, minimal number of studies and very low-quality evidence.
子宫肌瘤是女性生殖道最常见的良性肿瘤，与众多临床问题相关，包括可能对生育产生负面影响。对于要求保留生育功能的女性，可根据肌瘤的大小、位置和类型，通过开腹手术、腹腔镜手术或宫腔镜手术切除肌瘤（肌瘤切除术）。然而，肌瘤切除术是一种并非没有风险的手术，可能导致严重并发症。因此，确定该手术是否能提高生育能力，以及如果能提高，确定理想的手术方式至关重要。
研究肌瘤切除术对生育结局的影响，并比较不同的手术方式。
我们检索了Cochrane妇科与生育组（CGFG）专业注册库、Cochrane系统评价数据库、医学期刊数据库、Embase数据库（荷兰医学文摘数据库）、心理学文摘数据库、护理学与健康领域数据库、循证医学数据库、世界卫生组织（WHO）国际临床试验注册平台检索入口、效果评价文摘数据库（DARE）、拉丁美洲和加勒比地区卫生科学数据库、科学网会议摘要、欧洲灰色文献数据库OpenSigle以及相关论文的参考文献列表。最终检索时间为2019年2月。
随机对照试验（RCT），比较肌瘤切除术与不干预的效果，或比较不同手术方式对一组患有子宫肌瘤的不孕女性生育结局的影响。
数据收集与分析按照Cochrane干预措施系统评价手册中建议的程序进行。
本综述纳入了4项RCT，共442名参与者。证据质量极低，主要局限性在于严重的不精确性、不一致性和间接性。肌瘤切除术与不干预：一项研究比较了肌瘤切除术与不干预对生殖结局的影响。我们不确定肌瘤切除术是否能提高肌壁间肌瘤的临床妊娠率（比值比（OR）1.88，95%置信区间（CI）0.57至6.14；45名参与者；一项研究；极低质量证据）、黏膜下肌瘤的临床妊娠率（OR 2.04，95%CI 0.62至6.66；52名参与者；一项研究；极低质量证据）、肌壁间/浆膜下肌瘤（OR 2.00，95%CI 0.40至10.09；31名参与者；一项研究；极低质量证据）或肌壁间/黏膜下肌瘤（OR 3.24，95%CI 0.72至14.57；42名参与者；一项研究；极低质量证据）。同样，我们不确定肌瘤切除术是否能降低肌壁间肌瘤的流产率（OR 1.33，95%CI 0.26至6.78；45名参与者；一项研究；极低质量证据）、黏膜下肌瘤的流产率（OR 1.27，95%CI 0.27至5.97；52名参与者；一项研究；极低质量证据）、肌壁间/浆膜下肌瘤（OR 0.80，95%CI 0.10至6.54；31名参与者；一项研究；极低质量证据）或肌壁间/黏膜下肌瘤（OR 2.00，95%CI 0.32至12.33；42名参与者；一项研究；极低质量证据）。该研究未报告活产、早产、持续妊娠或剖宫产率。腹腔镜肌瘤切除术与开腹或小切口开腹肌瘤切除术：两项研究比较了腹腔镜肌瘤切除术与开腹或小切口开腹肌瘤切除术。我们不确定与开腹或小切口开腹肌瘤切除术相比，腹腔镜肌瘤切除术是否能提高活产率（OR 0.80，95%CI 0.42至1.50；177名参与者；两项研究；I = 0%；极低质量证据）、早产率（OR 0.70，95%CI 0.11至4.29；参与者 = 177；两项研究；I = 0%，极低质量证据）、临床妊娠率（OR 0.96，95%CI 0.52至1.78；177名参与者；两项研究；I = 0%，极低质量证据）、持续妊娠率（OR 1.61，95%CI 0.26至10.04；115名参与者；一项研究；极低质量证据）、流产率（OR 1.25，95%CI 0.40至3.89；参与者 = 177；两项研究；I = 0%，极低质量证据）或剖宫产率（OR 0.69，95%CI 0.34至`1.39；参与者 = 177；两项研究；I = 21%，极低质量证据）。单极电切镜与双极电切镜：一项研究评估了宫腔镜肌瘤切除术中两种电外科系统的使用。我们不确定与单极电切镜相比，使用双极电切镜是否能提高活产/持续妊娠率（OR 0.86，95%CI 0.30至2.50；68名参与者；一项研究，极低质量证据）、临床妊娠率（OR 0.88，95%CI 0.33至2.36；68名参与者；一项研究；极低质量证据）或流产率（OR 1.00，95%CI 0.19至5.34；参与者 = 68；一项研究；极低质量证据）。该研究未报告早产或剖宫产率。
由于仅有一项试验比较了肌瘤切除术与未行肌瘤切除术，因此确定肌瘤切除术对肌瘤患者不孕的作用的证据有限。如果决定进行肌瘤切除术，目前的证据并未表明哪种方法（腹腔镜手术、开腹手术或不同的电外科系统）能提高活产率、早产率、临床妊娠率、持续妊娠率、流产率或剖宫产率。此外，由于事件数量少、研究数量有限且证据质量极低，现有证据需谨慎看待。
