机器人助手与人类或另一个机器人助手在接受腹腔镜胆囊切除术患者中的比较。

Robot assistant versus human or another robot assistant in patients undergoing laparoscopic cholecystectomy.

作者信息

Gurusamy Kurinchi Selvan, Samraj Kumarakrishnan, Fusai Giuseppe, Davidson Brian R

机构信息

Department of Surgery, Royal Free Campus, UCL Medical School, London, UK.

出版信息

Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD006578. doi: 10.1002/14651858.CD006578.pub3.

Abstract

BACKGROUND

The role of a robotic assistant in laparoscopic cholecystectomy is controversial. While some trials have shown distinct advantages of a robotic assistant over a human assistant others have not, and it is unclear which robotic assistant is best.

OBJECTIVES

The aims of this review are to assess the benefits and harms of a robot assistant versus human assistant or versus another robot assistant in laparoscopic cholecystectomy, and to assess whether the robot can substitute the human assistant.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded (until February 2012) for identifying the randomised clinical trials.

SELECTION CRITERIA

Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing robot assistants versus human assistants in laparoscopic cholecystectomy were considered for the review. Randomised clinical trials comparing different types of robot assistants were also considered for the review.

DATA COLLECTION AND ANALYSIS

Two authors independently identified the trials for inclusion and independently extracted the data. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI) using the fixed-effect and the random-effects models based on intention-to-treat analysis, when possible, using Review Manager 5.

MAIN RESULTS

We included six trials with 560 patients. One trial involving 129 patients did not state the number of patients randomised to the two groups. In the remaining five trials 431 patients were randomised, 212 to the robot assistant group and 219 to the human assistant group. All the trials were at high risk of bias. Mortality and morbidity were reported in only one trial with 40 patients. There was no mortality or morbidity in either group. Mortality and morbidity were not reported in the remaining trials. Quality of life or the proportion of patients who were discharged as day-patient laparoscopic cholecystectomy patients were not reported in any trial. There was no significant difference in the proportion of patients who required conversion to open cholecystectomy (2 trials; 4/63 (weighted proportion 6.4%) in the robot assistant group versus 5/70 (7.1%) in the human assistant group; RR 0.90; 95% CI 0.25 to 3.20). There was no significant difference in the operating time between the two groups (4 trials; 324 patients; MD 5.00 minutes; 95% CI -0.55 to 10.54). In one trial, about one sixth of the laparoscopic cholecystectomies in which a robot assistant was used required temporary use of a human assistant. In another trial, there was no requirement for human assistants. One trial did not report this information. It appears that there was little or no requirement for human assistants in the other three trials. There were no randomised trials comparing one type of robot versus another type of robot.

AUTHORS' CONCLUSIONS: Robot assisted laparoscopic cholecystectomy does not seem to offer any significant advantages over human assisted laparoscopic cholecystectomy. However, all trials had a high risk of systematic errors or bias (that is, risk of overestimation of benefit and underestimation of harm). All trials were small, with few or no outcomes. Hence, the risk of random errors (that is, play of chance) is high. Further randomised trials with low risk of bias or random errors are needed.

摘要

背景

机器人辅助在腹腔镜胆囊切除术中的作用存在争议。虽然一些试验显示机器人辅助相对于人类辅助有明显优势,但其他试验则不然,而且尚不清楚哪种机器人辅助最佳。

目的

本综述的目的是评估在腹腔镜胆囊切除术中,机器人辅助与人类辅助或另一种机器人辅助相比的益处和危害,并评估机器人是否能替代人类辅助。

检索方法

我们检索了《 Cochr ane图书馆》中的 Cochr ane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版(截至2012年2月),以识别随机临床试验。

选择标准

本综述仅纳入在腹腔镜胆囊切除术中比较机器人辅助与人类辅助的随机临床试验(无论语言、盲法或发表状态如何)。比较不同类型机器人辅助的随机临床试验也纳入本综述。

数据收集与分析

两位作者独立确定纳入试验并独立提取数据。我们尽可能使用RevMan ager 5,基于意向性分析,采用固定效应和随机效应模型计算风险比(RR)或平均差(MD)及95%置信区间(CI)。

主要结果

我们纳入了6项试验,共560例患者。一项涉及129例患者的试验未说明随机分配到两组的患者数量。在其余5项试验中,431例患者被随机分组,212例分到机器人辅助组,219例分到人类辅助组。所有试验均存在高偏倚风险。仅一项纳入40例患者的试验报告了死亡率和发病率。两组均无死亡或发病情况。其余试验未报告死亡率和发病率。任何试验均未报告生活质量或作为日间腹腔镜胆囊切除术患者出院的患者比例。在需要转为开腹胆囊切除术的患者比例方面无显著差异(2项试验;机器人辅助组4/63(加权比例6.4%),人类辅助组5/70(7.1%);RR 0.90;95%CI 0.25至3.20)。两组手术时间无显著差异(4项试验;324例患者;MD 5.00分钟;95%CI -0.55至10.54)。在一项试验中,使用机器人辅助的腹腔镜胆囊切除术中约六分之一需要临时使用人类辅助。在另一项试验中,无需人类辅助。一项试验未报告此信息。在其他三项试验中,似乎很少或根本不需要人类辅助。没有随机试验比较一种机器人与另一种机器人。

作者结论

机器人辅助腹腔镜胆囊切除术似乎并不比人类辅助腹腔镜胆囊切除术有任何显著优势。然而,所有试验均存在高系统误差或偏倚风险(即高估益处和低估危害的风险)。所有试验规模都小,结局很少或没有。因此,随机误差(即机遇作用)风险高。需要开展偏倚或随机误差风险低的进一步随机试验。

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