Galaal Khadra, Donkers Hannah, Bryant Andrew, Lopes Alberto D
Gynaecological Oncology, Princess Alexandra Wing, Royal Cornwall Hospital, Truro, UK, TR1 3LJ.
Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD006655. doi: 10.1002/14651858.CD006655.pub3.
This is an update of a previous Cochrane Review published in 2012, Issue 9.Surgery for endometrial cancer (hysterectomy with removal of both fallopian tubes and ovaries) is performed through laparotomy. It has been suggested that the laparoscopic approach is associated with a reduction in operative morbidity. Over the last two decades there has been a steady increase of the use of laparoscopy for endometrial cancer. This review investigated the evidence of benefits and harms of laparoscopic surgery compared with laparotomy for presumed early stage endometrial cancer.
To compare overall survival (OS) and disease free survival (DFS) for laparoscopic surgery versus laparotomy in women with presumed early stage endometrial cancer.
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 5) in the Cochrane Library, MEDLINE via Ovid (April 2012 to June 2018) and Embase via Ovid (April 2012 to June 2018). We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies. The trial registers included NHMRC Clinical Trials Register, UKCCCR Register of Cancer Trials, Meta-Register and Physician Data Query Protocol.
Randomised controlled trials (RCTs) comparing laparoscopy and laparotomy for early stage endometrial cancer.
We independently abstracted data and assessed risk of bias. We used hazard ratios (HRs) for OS and recurrence free survival (RFS), risk ratios (RR) for severe adverse events and mean differences (MD) for continuous outcomes in women who received laparoscopy or laparotomy with 9% confidence intervals (CI). These were pooled in random-effects meta-analyses.
We identified one new study in this update of the review. The review contains nine RCTs comparing laparoscopy with laparotomy for the surgical management of early stage endometrial cancer.All nine studies met the inclusion criteria and assessed 4389 women at the end of the studies. Six studies assessing 3993 participants with early stage endometrial cancer found no significant difference in the risk of death between women who underwent laparoscopy and women who underwent laparotomy (HR 1.04, 95% 0.86 to 1.25; moderate-certainty evidence) and five studies assessing 3710 participants found no significant difference in the risk of recurrence between the laparoscopy and laparotomy groups (HR 1.14, 95% CI 0.90 to 1.43; moderate-certainty evidence). There was no significant difference in the rate of perioperative death; women requiring a blood transfusion; and bladder, ureteric, bowel and vascular injury. However, one meta-analysis of three studies found that women in the laparoscopy group lost significantly less blood than women in the laparotomy group (MD -106.82 mL, 95% CI -141.59 to -72.06; low-certainty evidence). A further meta-analysis of two studies, which assessed 3344 women and included one very large trial of over 2500 participants, found that there was no clinical difference in the risk of severe postoperative complications in women in the laparoscopy and laparotomy groups (RR 0.78, 95% CI 0.44 to 1.38). Most studies were at moderate risk of bias. All nine studies reported hospital stay and results showed that on average, laparoscopy was associated with a significantly shorter hospital stay.
AUTHORS' CONCLUSIONS: This review found low to moderate-certainty evidence to support the role of laparoscopy for the management of early endometrial cancer. For presumed early stage primary endometrioid adenocarcinoma of the endometrium, laparoscopy is associated with similar OS and DFS. Furthermore, laparoscopy is associated with reduced operative morbidity and hospital stay. There is no significant difference in severe postoperative morbidity between the two modalities.The certainty of evidence for OS and RFS was moderate and was downgraded for unclear risk of bias profiles and imprecision in effect estimates. However, most studies used adequate methods of sequence generation and concealment of allocation so studies were not prone to selection bias. Adverse event outcomes were downgraded for the same reasons and additionally for low event rates and low power thus these outcomes provided low-certainty evidence.
这是对2012年第9期发表的一篇Cochrane系统评价的更新。子宫内膜癌手术(子宫切除术加双侧输卵管和卵巢切除术)通过剖腹术进行。有人提出,腹腔镜手术可降低手术发病率。在过去二十年中,腹腔镜用于子宫内膜癌的情况稳步增加。本评价调查了与剖腹术相比,腹腔镜手术对疑似早期子宫内膜癌的益处和危害的证据。
比较腹腔镜手术与剖腹术对疑似早期子宫内膜癌女性的总生存期(OS)和无病生存期(DFS)。
对于本次更新,我们检索了Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL;2018年第5期)、通过Ovid检索的MEDLINE(2012年4月至2018年6月)以及通过Ovid检索的Embase(2012年4月至2018年6月)。我们还检索了临床试验注册库、科学会议摘要以及纳入研究的参考文献列表。试验注册库包括NHMRC临床试验注册库、UKCCCR癌症试验注册库、Meta注册库和医师数据查询协议。
比较腹腔镜手术和剖腹术治疗早期子宫内膜癌的随机对照试验(RCT)。
我们独立提取数据并评估偏倚风险。我们使用风险比(HR)来评估OS和无复发生存期(RFS),使用风险比(RR)来评估严重不良事件,使用均值差(MD)来评估接受腹腔镜手术或剖腹术女性的连续结局,并给出9%置信区间(CI)。这些数据汇总在随机效应荟萃分析中。
在本次评价更新中,我们确定了一项新研究。该评价包含9项比较腹腔镜手术与剖腹术治疗早期子宫内膜癌的RCT。所有9项研究均符合纳入标准,研究结束时共评估了4389名女性。6项评估3993名早期子宫内膜癌参与者的研究发现,接受腹腔镜手术的女性与接受剖腹术的女性之间的死亡风险无显著差异(HR 1.04,95% CI 0.86至1.25;中等确定性证据),5项评估3710名参与者的研究发现,腹腔镜手术组和剖腹术组之间的复发风险无显著差异(HR 1.14,95% CI 0.90至1.43;中等确定性证据)。围手术期死亡率、需要输血的女性比例以及膀胱、输尿管、肠道和血管损伤方面无显著差异。然而,一项对3项研究的荟萃分析发现,腹腔镜手术组女性的失血量明显少于剖腹术组女性(MD -106.82 mL,95% CI -141.59至-72.06;低确定性证据)。另一项对2项研究的荟萃分析评估了3344名女性,其中包括一项超过2500名参与者的大型试验,发现腹腔镜手术组和剖腹术组女性术后严重并发症风险无临床差异(RR 0.78,95% CI 0.44至1.38)。大多数研究存在中度偏倚风险。所有9项研究均报告了住院时间,结果显示,平均而言,腹腔镜手术与显著缩短的住院时间相关。
本评价发现低至中等确定性证据支持腹腔镜手术在早期子宫内膜癌治疗中的作用。对于疑似早期原发性子宫内膜样腺癌,腹腔镜手术与相似的OS和DFS相关。此外,腹腔镜手术与手术发病率降低和住院时间缩短相关。两种手术方式术后严重发病率无显著差异。OS和RFS的证据确定性为中等,因偏倚风险情况不明和效应估计不精确而降级。然而,大多数研究采用了适当的随机序列生成和分配隐藏方法,因此研究不易出现选择偏倚。不良事件结局因相同原因以及事件发生率低和检验效能低而降级,因此这些结局提供低确定性证据。