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子宫内膜异位症的腹腔镜手术

Laparoscopic surgery for endometriosis.

作者信息

Bafort Celine, Beebeejaun Yusuf, Tomassetti Carla, Bosteels Jan, Duffy James Mn

机构信息

Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.

King's Fertility, King's College Hospital NHS Foundation Trust, London, UK.

出版信息

Cochrane Database Syst Rev. 2020 Oct 23;10(10):CD011031. doi: 10.1002/14651858.CD011031.pub3.

Abstract

BACKGROUND

Endometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy.

OBJECTIVES

To assess the effectiveness and safety of laparoscopic surgery in the treatment of pain and infertility associated with endometriosis.

SEARCH METHODS

This review has drawn on the search strategy developed by the Cochrane Gynaecology and Fertility Group including searching the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, reference lists for relevant trials, and trial registries from inception to April 2020.

SELECTION CRITERIA

We selected randomised controlled trials (RCTs) that compared the effectiveness and safety of laparoscopic surgery with any other laparoscopic or robotic intervention, holistic or medical treatment, or diagnostic laparoscopy only.

DATA COLLECTION AND ANALYSIS

Two review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data with disagreements resolved by a third review author. We collected data for the core outcome set for endometriosis. Primary outcomes included overall pain and live birth. We evaluated the quality of evidence using GRADE methods.

MAIN RESULTS

We included 14 RCTs. The studies randomised 1563 women with endometriosis. Four RCTs compared laparoscopic ablation or excision with diagnostic laparoscopy only. Two RCTs compared laparoscopic excision with diagnostic laparoscopy only. One RCT compared laparoscopic ablation or excision with laparoscopic ablation or excision and uterine suspension. Two RCTs compared laparoscopic ablation and uterine nerve transection with diagnostic laparoscopy only. One RCT compared laparoscopic ablation with diagnostic laparoscopy and gonadotropin-releasing hormone (GnRH) analogues. Two RCTs compared laparoscopic ablation with laparoscopic excision. One RCT compared laparoscopic ablation or excision with helium thermal coagulator with laparoscopic ablation or excision with electrodiathermy. One RCT compared conservative laparoscopic surgery with laparoscopic colorectal resection of deep endometriosis infiltrating the rectum. Common limitations in the primary studies included lack of clearly described blinding, failure to fully describe methods of randomisation and allocation concealment, and poor reporting of outcome data. Laparoscopic treatment versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic treatment on overall pain scores compared to diagnostic laparoscopy only at six months (mean difference (MD) 0.90, 95% confidence interval (CI) 0.31 to 1.49; 1 RCT, 16 participants; very low quality evidence) and at 12 months (MD 1.65, 95% CI 1.11 to 2.19; 1 RCT, 16 participants; very low quality evidence), where a positive value means pain relief (the higher the score, the more pain relief) and a negative value reflects pain increase (the lower the score, the worse the increase in pain). No studies looked at live birth. We are uncertain of the effect of laparoscopic treatment on quality of life compared to diagnostic laparoscopy only: EuroQol-5D index summary at six months (MD 0.03, 95% CI -0.12 to 0.18; 1 RCT, 39 participants; low quality evidence), 12-item Short Form (SF-12) mental health component (MD 2.30, 95% CI -4.50 to 9.10; 1 RCT, 39 participants; low quality evidence) and SF-12 physical health component (MD 2.70, 95% CI -2.90 to 8.30; 1 RCT, 39 participants; low quality evidence). Laparoscopic treatment probably improves viable intrauterine pregnancy rate compared to diagnostic laparoscopy only (odds ratio (OR) 1.89, 95% CI 1.25 to 2.86; 3 RCTs, 528 participants; I = 0%; moderate quality evidence). We are uncertain of the effect of laparoscopic treatment compared to diagnostic laparoscopy only on ectopic pregnancy (MD 1.18, 95% CI 0.10 to 13.48; 1 RCT, 100 participants; low quality evidence) and miscarriage (MD 0.94, 95% CI 0.35 to 2.54; 2 RCTs, 112 participants; low quality evidence). There was limited reporting of adverse events. No conversions to laparotomy were reported in both groups (1 RCT, 341 participants). Laparoscopic ablation and uterine nerve transection versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic ablation and uterine nerve transection on adverse events (more specifically vascular injury) compared to diagnostic laparoscopy only (OR 0.33, 95% CI 0.01 to 8.32; 1 RCT, 141 participants; low quality evidence). No studies looked at overall pain scores (at six and 12 months), live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage. Laparoscopic ablation versus laparoscopic excision There was insufficient evidence to determine whether there was a difference in overall pain, measured at 12 months, for laparoscopic ablation compared with laparoscopic excision (MD 0.00, 95% CI -1.22 to 1.22; 1 RCT, 103 participants; very low quality evidence). No studies looked at overall pain scores at six months, live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy, miscarriage and adverse events. Helium thermal coagulator versus electrodiathermy We are uncertain whether helium thermal coagulator compared to electrodiathermy improves quality of life using the 30-item Endometriosis Health Profile (EHP-30) at nine months, when considering the components: pain (MD 6.68, 95% CI -3.07 to 16.43; 1 RCT, 119 participants; very low quality evidence), control and powerlessness (MD 4.79, 95% CI -6.92 to 16.50; 1 RCT, 119 participants; very low quality evidence), emotional well-being (MD 6.17, 95% CI -3.95 to 16.29; 1 RCT, 119 participants; very low quality evidence) and social support (MD 5.62, 95% CI -6.21 to 17.45; 1 RCT, 119 participants; very low quality evidence). Adverse events were not estimable. No studies looked at overall pain scores (at six and 12 months), live birth, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage.

AUTHORS' CONCLUSIONS: Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. No data were reported on live birth. There is moderate quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only. No studies were found that looked at live birth for any of the comparisons. Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.

摘要

背景

子宫内膜异位症与疼痛和不孕有关。手术干预旨在切除子宫内膜异位症的可见区域并恢复解剖结构。

目的

评估腹腔镜手术治疗与子宫内膜异位症相关的疼痛和不孕的有效性和安全性。

检索方法

本综述采用了Cochrane妇科与生育组制定的检索策略,包括检索Cochrane妇科与生育组的专业注册库、CENTRAL、MEDLINE、Embase、PsycINFO、CINAHL、相关试验的参考文献列表以及从创刊至2020年4月的试验注册库。

选择标准

我们选择了随机对照试验(RCT),这些试验比较了腹腔镜手术与其他任何腹腔镜或机器人干预、整体或药物治疗或仅诊断性腹腔镜检查的有效性和安全性。

数据收集与分析

两位综述作者独立进行研究选择、试验质量评估和相关数据提取,分歧由第三位综述作者解决。我们收集了子宫内膜异位症核心结局集的数据。主要结局包括总体疼痛和活产。我们使用GRADE方法评估证据质量。

主要结果

我们纳入了14项RCT。这些研究将1563名患有子宫内膜异位症的女性随机分组。4项RCT比较了腹腔镜消融或切除与仅诊断性腹腔镜检查。2项RCT比较了腹腔镜切除与仅诊断性腹腔镜检查。1项RCT比较了腹腔镜消融或切除与腹腔镜消融或切除及子宫悬吊术。2项RCT比较了腹腔镜消融和子宫神经切断术与仅诊断性腹腔镜检查。1项RCT比较了腹腔镜消融与诊断性腹腔镜检查及促性腺激素释放激素(GnRH)类似物。2项RCT比较了腹腔镜消融与腹腔镜切除。1项RCT比较了腹腔镜消融或切除联合氦热凝器与腹腔镜消融或切除联合电凝术。1项RCT比较了保守性腹腔镜手术与腹腔镜结直肠切除术治疗浸润直肠的深部子宫内膜异位症。原始研究的常见局限性包括缺乏对盲法的清晰描述、未能充分描述随机化和分配隐藏方法以及结局数据报告不佳。腹腔镜治疗与诊断性腹腔镜检查相比:我们不确定与仅诊断性腹腔镜检查相比,腹腔镜治疗在6个月时对总体疼痛评分的影响(平均差(MD)0.90,95%置信区间(CI)0.31至1.49;1项RCT,16名参与者;极低质量证据)以及在12个月时的影响(MD 1.65,95%CI 1.11至2.19;1项RCT,16名参与者;极低质量证据)。正值表示疼痛缓解(分数越高,疼痛缓解越明显),负值反映疼痛增加(分数越低,疼痛增加越严重)。没有研究观察活产情况。我们不确定与仅诊断性腹腔镜检查相比,腹腔镜治疗对生活质量的影响:6个月时的EuroQol - 5D指数总结(MD 0.03,95%CI -0.12至0.18;1项RCT,39名参与者;低质量证据)、12项简短健康调查(SF - 12)心理健康分量表(MD 2.30,95%CI -4.50至9.10;1项RCT,39名参与者;低质量证据)和SF - 12身体健康分量表(MD 2.70,95%CI -2.90至8.30;1项RCT,39名参与者;低质量证据)。与仅诊断性腹腔镜检查相比,腹腔镜治疗可能会提高超声确认的宫内活胎妊娠率(优势比(OR)1.89,95%CI 1.25至2.86;3项RCT,528名参与者;I² = 0%;中等质量证据)。我们不确定与仅诊断性腹腔镜检查相比,腹腔镜治疗对异位妊娠(MD 1.18,95%CI 0.10至13.48;1项RCT,100名参与者;低质量证据)和流产(MD 0.94,95%CI 0.35至2.54;2项RCT,112名参与者;低质量证据)的影响。不良事件的报告有限。两组均未报告转为开腹手术的情况(1项RCT,341名参与者)。腹腔镜消融和子宫神经切断术与诊断性腹腔镜检查相比:我们不确定与仅诊断性腹腔镜检查相比,腹腔镜消融和子宫神经切断术对不良事件(更具体地说是血管损伤)的影响(OR 0.33,95%CI 0.01至8.32;1项RCT,141名参与者;低质量证据)。没有研究观察总体疼痛评分(6个月和12个月时)、活产、生活质量、超声确认的宫内活胎妊娠、异位妊娠和流产情况。腹腔镜消融与腹腔镜切除相比:没有足够的证据确定与腹腔镜切除相比,腹腔镜消融在12个月时测量的总体疼痛是否存在差异(MD 0.00,95%CI -1.22至1.22;1项RCT,103名参与者;极低质量证据)。没有研究观察6个月时的总体疼痛评分、活产、生活质量、超声确认的宫内活胎妊娠、异位妊娠、流产和不良事件。氦热凝器与电凝术相比:当考虑以下分量表时,我们不确定与电凝术相比,氦热凝器在9个月时使用30项子宫内膜异位症健康概况(EHP - 30)是否能改善生活质量:疼痛(MD 6.68,95%CI -3.07至16.43;1项RCT,119名参与者;极低质量证据)、控制感和无助感(MD 4.79,95%CI -6.92至16.50;1项RCT,11

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