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腹腔镜手术与开腹手术治疗早期子宫内膜癌的比较

Laparoscopy versus laparotomy for the management of early stage endometrial cancer.

作者信息

Galaal Khadra, Bryant Andrew, Fisher Ann D, Al-Khaduri Maha, Kew Fiona, Lopes Alberto D

机构信息

Gynaecological Oncology, Princess Alexandra Wing, Royal Cornwall Hospital, Truro, UK.

出版信息

Cochrane Database Syst Rev. 2012 Sep 12(9):CD006655. doi: 10.1002/14651858.CD006655.pub2.

Abstract

BACKGROUND

Traditionally, 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 10 to 15 years there has been a steady increase of laparoscopy for endometrial cancer. This review investigates the evidence of benefits and harms of laparoscopic surgery compared with laparotomy for presumed early stage endometrial cancer.

OBJECTIVES

To compare the overall survival (OS) and disease-free survival (DFS) for laparoscopic surgery versus laparotomy in women with presumed early stage endometrial cancer.

SEARCH METHODS

We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) Issue 3, 2012, MEDLINE, EMBASE and CINAHL up to April 2012. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies. Trial registers we searched included NHMRC Clinical Trials Register, UKCCCR Register of Cancer Trials, Meta-Register and Physician Data Query Protocol, as well as abstracts of scientific meetings.

SELECTION CRITERIA

Randomised controlled trials (RCTs) comparing laparoscopy and laparotomy for early stage endometrial cancer.

DATA COLLECTION AND ANALYSIS

We independently abstracted data and assessed risk of bias. Hazard ratios (HRs) were used for OS and recurrence-free survival (RFS), risk ratios (RR) for severe adverse events and the mean difference (MD) method was used for continuous outcomes in women who received laparoscopy or laparotomy and these were then pooled in random-effects meta-analyses.

MAIN RESULTS

Eight RCTs comparing laparoscopy with laparotomy for the surgical management of early stage endometrial cancer were identified.All eight trials met the inclusion criteria, 3644 women were assessed at the end of the trials. Three trials assessing 359 participants with early stage endometrial cancer, found no statistically significant difference in the risk of death and disease or recurrence between women who underwent laparoscopy and those who underwent laparotomy (HR = 1.14, 95% confidence interval (CI): 0.62 to 2.10) and HR = 1.13, 95% CI: 0.90 to 1.42 for OS and RFS respectively). There was no statistically significant difference in the rate of peri-operative death, women requiring a blood transfusion, and bladder, ureteric, bowel and vascular injury. However, a meta-analysis of two trials found that women in the laparoscopy group lost significantly less blood than those in the laparotomy group (MD = -106.82 mL, 95% CI: -141.59 to -72.06). A further meta-analysis of two trials, which assessed 2923 women and included one very large trial of over 2500 participants, found that the rate of severe post-operative adverse events was significantly lower in the laparoscopy group compared with the laparotomy group (RR = 0.58, 95% CI: 0.37 to 0.91). The large trial did not give a breakdown of these severe post-operative adverse events into different adverse event categories. Most trials were at moderate risk of bias. Hospital stay was reported in all of the trials and results show that on average, laparoscopy was associated with a significantly shorter hospital stay.

AUTHORS' CONCLUSIONS: This review has found 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 overall and disease-free survival. Laparoscopy is associated with reduced operative morbidity and hospital stay. There is no significant difference in severe post-operative morbidity between the two modalities.

摘要

背景

传统上,子宫内膜癌手术(子宫切除并切除双侧输卵管和卵巢)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10至15年中,子宫内膜癌腹腔镜手术的应用稳步增加。本综述调查了与剖腹术相比,腹腔镜手术治疗疑似早期子宫内膜癌的益处和危害的证据。

目的

比较腹腔镜手术与剖腹术治疗疑似早期子宫内膜癌女性的总生存期(OS)和无病生存期(DFS)。

检索方法

我们检索了Cochrane妇科癌症组试验注册库、Cochrane对照试验中央注册库(CENTRAL)2012年第3期、MEDLINE、EMBASE和CINAHL,检索截至2012年4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。我们检索的试验注册库包括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,以及科学会议摘要。

选择标准

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)。

数据收集与分析

我们独立提取数据并评估偏倚风险。总生存期(OS)和无复发生存期(RFS)采用风险比(HR),严重不良事件采用风险比(RR),接受腹腔镜手术或剖腹术的女性的连续结局采用均值差(MD)方法,然后将这些数据汇总到随机效应荟萃分析中。

主要结果

确定了8项比较腹腔镜手术和剖腹术治疗早期子宫内膜癌的RCT。所有8项试验均符合纳入标准,试验结束时评估了3644名女性。三项试验评估了359名早期子宫内膜癌患者,发现接受腹腔镜手术的女性与接受剖腹术的女性在死亡、疾病或复发风险方面无统计学显著差异(OS的HR = 1.14,95%置信区间(CI):0.62至2.10;RFS的HR = 1.13,95%CI:0.90至1.42)。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统计学显著差异。然而,两项试验的荟萃分析发现,腹腔镜手术组女性的失血量明显少于剖腹术组(MD = -106.82 mL,95%CI:-141.59至-72.06)。对两项试验的进一步荟萃分析评估了2923名女性,其中包括一项超过2500名参与者的大型试验,发现腹腔镜手术组的严重术后不良事件发生率明显低于剖腹术组(RR = 0.58,95%CI:0.37至0.91)。大型试验未将这些严重术后不良事件细分为不同的不良事件类别。大多数试验存在中度偏倚风险。所有试验均报告了住院时间,结果显示,平均而言,腹腔镜手术与明显缩短的住院时间相关。

作者结论

本综述发现有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总生存期和无病生存期相关。腹腔镜手术与降低手术发病率和缩短住院时间相关。两种手术方式在严重术后发病率方面无显著差异。

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