Liu Hongqian, Lu DongHao, Wang Lei, Shi Gang, Song Huan, Clarke Jane
Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2012 Feb 15(2):CD008978. doi: 10.1002/14651858.CD008978.pub2.
Robotic surgery is the latest innovation in the field of minimally invasive surgery. In the case of robotic surgery, instead of directly moving the instruments the surgeon uses a robotic system to control the instruments for surgical procedures. Robotic surgical systems have been used in various gynaecological surgeries for benign disease, such as hysterectomy (removal of the uterus), myomectomy (removal of uterine leiomyomas) and tubal reanastomosis (the reuniting of a divided tube). The mounting evidence demonstrates the feasibility and safety of robotic surgery in benign gynaecological disease. Robotic surgery is advertised as having promising advantages including more precise vision and procedures, improved ergonomics and shorter length of hospital stay. However, the main disadvantages of the robotic surgical system should not be overlooked, including the high cost of disposable instruments and retraining for both surgeons and nurses.
To assess the effectiveness and safety of robot-assisted surgery in the treatment of benign gynaecological disease.
We searched the Cochrane Menstrual Disorders and Subfertility Group's Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2011), MEDLINE and EMBASE up to November 2011 and citation lists of relevant publications.
All randomised controlled trials (RCTs) comparing robotic surgery for benign gynaecological disease to laparoscopic or open surgical procedures. RCTs comparing different types of robotic assistants were also included. We contacted study authors for unpublished information, but failed in obtaining a response.
Two review authors independently screened studies for inclusion. The domains assessed for risk of bias were allocation concealment, blinding, incomplete outcome data and selective outcome reporting. Odds ratios (OR) were used for reporting dichotomous data with 95% confidence intervals (CI), whilst mean differences (MD) were determined for continuous data. Statistical heterogeneity was assessed using the I(2) statistic. We contacted the primary authors for missing data but failed in obtaining a response.
Two trials involving 158 participants were included. Since one included trial was published in conference proceedings, limited usable data were available for further analysis. The only analysis in this trial showed comparable rates of conversions to open surgery between the robotic group and the laparoscopic group (OR 1.41, 95% CI 0.22 to 9.01; P = 0.72). One RCT showed longer operation time (MD 66.00, 95% CI 40.93 to 91.07; P < 0.00001), higher cost (MD 1936.00, 95% CI 445.69 to 3426.31; P = 0.01) in the robotic group compared with the laparoscopic group. Also, both studies reported that robotic and laparoscopic surgery seemed comparable regarding intraoperative outcome, complications, length of hospital stay and quality of life.
AUTHORS' CONCLUSIONS: Currently, the limited evidence showed that robotic surgery did not benefit women with benign gynaecological disease in effectiveness or in safety. Further well-designed RCTs with complete reported data are required to confirm or refute this conclusion.
机器人手术是微创手术领域的最新创新。在机器人手术中,外科医生不是直接操作器械,而是使用机器人系统来控制手术过程中的器械。机器人手术系统已被用于各种治疗良性疾病的妇科手术,如子宫切除术(切除子宫)、子宫肌瘤切除术(切除子宫平滑肌瘤)和输卵管再吻合术(重新连接断开的输卵管)。越来越多的证据表明机器人手术在妇科良性疾病治疗中的可行性和安全性。机器人手术被宣传具有诸多潜在优势,包括视野和操作更精确、人体工程学设计改善以及住院时间缩短。然而,机器人手术系统的主要缺点也不应被忽视,包括一次性器械成本高昂以及外科医生和护士都需要重新培训。
评估机器人辅助手术治疗妇科良性疾病的有效性和安全性。
我们检索了Cochrane月经紊乱与生育力低下小组试验注册库、Cochrane对照试验中心注册库(CENTRAL)(2011年第2期)、截至2011年11月的MEDLINE和EMBASE以及相关出版物的参考文献列表。
所有比较机器人手术治疗妇科良性疾病与腹腔镜手术或开放手术的随机对照试验(RCT)。也纳入比较不同类型机器人辅助设备的RCT。我们联系了研究作者以获取未发表的信息,但未得到回复。
两位综述作者独立筛选纳入研究。评估偏倚风险的领域包括分配隐藏、盲法、不完整的结局数据和选择性结局报告。比值比(OR)用于报告二分数据并给出95%置信区间(CI),而对于连续数据则确定均值差(MD)。使用I²统计量评估统计异质性。我们联系了主要作者以获取缺失数据,但未得到回复。
纳入了两项涉及158名参与者的试验。由于其中一项纳入试验发表于会议论文集,可用于进一步分析的数据有限。该试验中的唯一分析显示机器人手术组和腹腔镜手术组转为开放手术的比例相当(OR 1.41,95% CI 0.22至9.01;P = 0.72)。一项RCT显示,与腹腔镜手术组相比,机器人手术组的手术时间更长(MD 66.00,95% CI 40.93至91.07;P < 0.00001),成本更高(MD 1936.00,95% CI 445.69至3426.31;P = 0.01)。此外,两项研究均报告,在术中结局、并发症、住院时间和生活质量方面,机器人手术和腹腔镜手术似乎相当。
目前,有限的证据表明机器人手术在有效性或安全性方面对患有妇科良性疾病的女性并无益处。需要进一步设计完善且数据报告完整的RCT来证实或反驳这一结论。