Liu Hongqian, Lawrie Theresa A, Lu DongHao, Song Huan, Wang Lei, Shi Gang
Department of Obstetrics and Gynecology,West China Second University Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2014 Dec 10;2014(12):CD011422. doi: 10.1002/14651858.CD011422.
This is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.
To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 5) and the Cochrane Gynaecological Cancer Review Group Trials Register. We also searched MEDLINE and EMBASE databases, to complement the searches of the original malignant and benign disease reviews (conducted up to July 2010 and November 2011, respectively), from July 2010 to June 2014.
Randomised controlled trials (RCTs) of RAS compared with CLS or open surgery in women requiring surgery for gynaecological disease.
Two review authors independently assessed the studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We subgrouped data according to type of procedure and pooled data using random-effects methods in RevMan 5.3. We performed sensitivity analyses by excluding studies at high risk of bias.
We included six RCTs involving 517 women. Most were at low to moderate overall risk of bias; one was at high risk of bias. Four studies evaluated RAS for hysterectomy (371 women), and two studies evaluated RAS for sacrocolpopexy (146 women). All studies compared RAS with CLS, except for one study, which compared RAS with CLS or a vaginal surgical approach for hysterectomy. Confidence intervals for the risk of intraoperative and postoperative complications included benefits with either approach when they were analysed together (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.46 to 1.99; participants = 513; studies = 6; I(2) = 74%) and separately (low-quality evidence). Moderate-quality evidence was found for the effects of RAS on intraoperative injury when compared with CLS (RR 1.23, 95% CI 0.44 to 3.46; participants = 415; studies = 5; I(2) = 0%), along with low-quality evidence for bleeding and infection complications.Mean total operating time was consistent across procedures and on average was about 42 minutes longer in the RAS arm compared with the CLS arm (95% CI 17 to 66 minutes; participants = 294; studies = 4; I(2) = 82%; moderate-quality evidence). Mean hospital stay for hysterectomy procedures was on average about seven hours shorter in the RAS arm than in the CLS arm (mean difference (MD) -0.30 days, 95% CI -0.54 to -0.06; participants = 217; studies = 2; I(2) = 0%; low-quality evidence). The estimated effect of conversion with RAS compared with CLS was imprecise (RR 1.28, 95% CI 0.40 to 4.12; participants = 337; studies = 4; I(2) = 0%; moderate-quality evidence). Limited data from two studies suggest that RAS for sacrocolpopexy may be associated with increased postoperative pain compared with CLS; this needs further investigation. We identified five ongoing trials-four of cancer surgery.
AUTHORS' CONCLUSIONS: We are uncertain as to whether RAS or CLS has lower intraoperative and postoperative complication rates because of the imprecision of the effect and inconsistency among studies when they are used for hysterectomy and sacrocolpopexy. Moderate-quality evidence suggests that these procedures take longer with RAS but may be associated with a shorter hospital stay following hysterectomy. We found limited evidence on the effectiveness and safety of RAS compared with CLS or open surgery for surgical procedures performed for gynaecological cancer; therefore its use should be limited to clinical trials. Ongoing trials are likely to have an important impact on evidence related to the use of RAS in gynaecology.
这是对两项原本独立的Cochrane综述进行更新后的合并综述：一项关于机器人辅助手术（RAS）用于良性妇科疾病，另一项关于RAS用于妇科癌症。RAS是腹腔镜手术中一项相对较新的创新技术，使外科医生能够在远离手术台的计算机控制台进行手术操作。RAS在美国已广泛用于子宫切除术，并且已证明对其他妇科手术也是可行的。然而，与传统腹腔镜手术（CLS）相比，RAS的临床有效性和安全性尚未明确确立，需要独立综述。
评估RAS治疗良性和恶性妇科疾病女性患者的有效性和安全性。
本次更新中，我们检索了Cochrane对照试验中心注册库（CENTRAL）（2014年第5期）和Cochrane妇科癌症综述组试验注册库。我们还检索了MEDLINE和EMBASE数据库，以补充原始恶性和良性疾病综述（分别截至2010年7月和2011年11月）在2010年7月至2014年6月期间的检索。
将RAS与CLS或开放手术进行比较的随机对照试验（RCT），这些试验涉及因妇科疾病需要手术的女性。
两位综述作者独立评估纳入研究及其偏倚风险，提取研究数据并录入Excel电子表格。我们根据手术类型对数据进行亚组分析，并使用RevMan 5.3中的随机效应方法合并数据。我们通过排除高偏倚风险的研究进行敏感性分析。
我们纳入了6项RCT，涉及517名女性。大多数研究总体偏倚风险为低至中度；一项研究为高偏倚风险。4项研究评估了RAS用于子宫切除术（371名女性），2项研究评估了RAS用于骶骨阴道固定术（146名女性）。除一项研究将RAS与CLS或子宫切除术的阴道手术入路进行比较外，所有研究均将RAS与CLS进行比较。术中及术后并发症风险的置信区间显示，两种手术方式综合分析时各有优势（风险比（RR）0.95，95%置信区间（CI）0.46至1.99；参与者 = 513；研究 = 6；I² = 74%），单独分析时为低质量证据。与CLS相比，RAS对术中损伤影响的证据质量为中等（RR 1.23，95% CI 0.44至3.46；参与者 = 415；研究 = 5；I² = 0%），出血和感染并发症为低质量证据。各手术的平均总手术时间一致，与CLS组相比，RAS组平均约长42分钟（95% CI 17至66分钟；参与者 = 294；研究 = 4；I² = 82%；中等质量证据）。子宫切除手术中，RAS组的平均住院时间比CLS组平均短约7小时（平均差（MD）-0.30天，95% CI -0.54至-0.06；参与者 = 217；研究 = 2；I² = 0%；低质量证据）。与CLS相比，RAS中转率的估计效应不精确（RR 1.28，95% CI 0.40至4.12；参与者 = 337；研究 = 4；I² = 0%；中等质量证据）。两项研究的有限数据表明，与CLS相比，骶骨阴道固定术采用RAS可能与术后疼痛增加有关；这需要进一步研究。我们确定了5项正在进行的试验——4项为癌症手术试验。
由于用于子宫切除术和骶骨阴道固定术时效应不精确且研究间不一致，我们不确定RAS或CLS的术中及术后并发症发生率是否更低。中等质量证据表明，这些手术采用RAS耗时更长，但子宫切除术后住院时间可能更短。与CLS或开放手术相比，我们发现RAS用于妇科癌症手术的有效性和安全性证据有限；因此其应用应限于临床试验。正在进行的试验可能会对RAS在妇科应用的相关证据产生重要影响。
