Robot assistant for laparoscopic cholecystectomy

 

Abstract

Background

The role of a robotic assistant in laparoscopic cholecystectomy is controversial. While some trials have shown distinct advantages of 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 compare the safety of robot assistant versus human assistant in laparoscopic cholecystectomy and to assess whether the robot can substitute for the human assistant.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until May 2008 for identifying the randomised trials using The Cochrane Hepato-Biliary Group search strategy.

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 exclusion and independently extracted the data. We calculated the risk ratio, mean difference, or standardised mean difference with 95% confidence intervals using the fixed-effect and the random-effects models based on available case-analysis using RevMan 5.

Main results

We included five trials (all of high risk of bias) with 453 patients randomised: 159 to the robot-assistant group and 165 to the human assistant group (one trial report of 129 patients was a conference abstract, not reporting on the number of patients in each group). There was no statistically significant difference between the two groups for morbidity, conversion to open cholecystectomy, total operating time, or hospital stay when fixed-effect or random-effects model were used. The instrument set-up time was significantly lower in the human assistant group. In one trial, about one sixth of the laparoscopic cholecystectomies in which robot assistant was used, required temporary use of a human assistant. It appears that there was little or no requirement for human assistants in the other three published trials. In two of the three trials, which reported surgeons' preference, the surgeons preferred a robot assistant to a human assistant. There was no statistically significant difference in the accuracy when the random-effects model was used. There was no difference in the errors.

Authors' conclusions

Although robot-assisted laparoscopic cholecystectomy appears safe, there seems to be no significant advantages over human-assisted laparoscopic cholecystectomy. We were unable to identify trials comparing one type of robot assistant versus another. Further randomised trials with low bias-risk and random errors are needed.

 

Plain language summary

Robot-assisted laparoscopic cholecystectomy appears safe but does not offer any advantage over human-assisted laparoscopic cholecystectomy

The role of a robotic assistant in laparoscopic cholecystectomy (removal of gallbladder by key-hole surgery) is controversial. In this systematic review comparing robot assistants with human assistants for laparoscopic cholecystectomy, we included five randomised clinical trials including 453 patients: 159 to the robot assistant group and 165 to the human assistant group (one trial report including 129 patients was a conference abstract and did not state the number of patients in each group). All the trials were of high risk of bias. There was no statistically significant difference between the two groups for morbidity, conversion to open cholecystectomy, total operating time, or hospital stay. The instrument set-up time was significantly lower in the human assistant group. In one trial, about one sixth of the laparoscopic cholecystectomies in which robot assistant was used, required temporary use of a human assistant. It appears that there was little or no requirement for human assistants in the other three published trials. In two of the three trials, which reported surgeons' preference, the surgeons preferred a robot assistant to a human assistant. Although robot-assisted laparoscopic cholecystectomy appears safe, there are no significant advantages over human-assisted laparoscopic cholecystectomy. Further randomised trials with low risk of bias (systematic errors) and low risk of play of chance (random errors) are needed.

 

摘要

背景

機器輔助手術用於腹腔鏡膽囊切除術

對於機器輔助手術應用於腹腔鏡膽囊切除術存有爭議。一些試驗明確的指出，機器輔助手術具有的優勢超過人類助手，但是其他研究卻無法苟同，所以我們並不清楚機器輔助手術是否是最佳的。

目標

本次文獻回顧目的在於評估機器輔助手術對照人類助手應用於腹腔鏡膽囊切除術的安全性，評估是否機器人可以取代人類助手。

搜尋策略

我們搜尋截至2008年5月The Cochrane HepatoBiliary Group Controlled Trials Register, Cochrane Library的Cochrane Central Register of Controlled Trials (CENTRAL)、 MEDLINE、EMBASE和Science Citation Index Expanded，使用Cochrane 肝膽小組研究策略確定隨機試驗。

選擇標準

本次回顧只考慮機器輔助手術對照人類助手應用於腹腔鏡膽囊切除術的隨機臨床試驗 (不受語言、盲法或發表狀況的限制)。 隨機臨床試驗比較不同的手術方法。

資料收集與分析

兩位作者單獨確定需要排除的試驗，摘錄數據。根據已獲取的個案分析，使用RevMan 5以固定效果和隨機效果模式評估風險比率(risk ratio)、平均差(mean difference)或標準平均差(standardised mean difference)，及其95% 信賴區間。

主要結論

我們包括5個隨機試驗 (所有試驗具有較高的偏誤風險)，共有453 位病人: 159 人被分配到機器輔助手術組，165 人被分配到人類助手組(1個有129位病人的試驗記錄屬於研討會摘要，沒有記錄每組的病人人數)。不管使用固定效果還是隨機效果模式，2組在發病率、轉換為開腹膽囊切除術，整體手術時間或住院日方面沒有統計學意義上的顯著差異。 人類助手組在工具設定時間上明顯較短。在一次實驗中，大約1/6使用機器輔助手術的腹腔鏡膽囊切除術需要臨時使用人類助手。在其他3次已發表的試驗中，對人類助手的需要很少或幾乎沒有。3個試驗有兩個試驗記錄到外科醫生的偏好，比起人類助手外科醫生更喜歡機器輔助手術。 隨機效果模式使用後，二者的精確度沒有統計學意義上的明顯差異。 誤差沒有差異。

作者結論

儘管機器人輔助的腹腔鏡膽囊切除術看似安全，但是也沒有出現明顯的優勢超過人類輔助的腹腔鏡膽囊切除術。 我們不確定有相互比較機器輔助手術的試驗，需要實施更多偏誤風險低的隨機試驗。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

儘管機器人輔助的腹腔鏡膽囊切除術看似安全，但是也沒有出現明顯的優勢超過人類輔助的腹腔鏡膽囊切除術: 人們對於機器輔助手術應用於腹腔鏡膽囊切除術存有爭議。本次系統性回顧比較應用於腹腔鏡膽囊切除術的機器輔助手術和人類助手。我們包括 5個隨機臨床試驗，共有453 位病人: 159人被分配到機器輔助手術組， 165 人被分配到人類助手組(1個有129位病人的試驗記錄屬於會議摘要，沒有記錄每組的病人人數)。所有試驗具有較高的偏見風險。兩組在發病率、轉換為開腹膽囊切除術、整體手術時間或住院日方面沒有統計學上顯著差異。人類助手組在工具設定時間上明顯較短。. 在一個實驗中，大約1/6使用機器輔助手術的腹腔鏡膽囊切除術需要臨時使用人類助手。在其他3個已發表的試驗中，對人類助手的需要很少或幾乎沒有。3個試驗有2個試驗記錄到外科醫生的偏好，比起人類助手外科醫生更喜歡機器輔助手術。儘管機器人輔助的腹腔鏡膽囊切除術看似安全，但是也沒有出現明顯的優勢超過人類輔助的腹腔鏡膽囊切除術。 未來需要實施更多的偏誤風險(誤差)低且機率誤差(隨機誤差)低的隨機試驗。