BACKGROUND: 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. OBJECTIVES: To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease. SEARCH METHODS: 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. SELECTION CRITERIA: Randomised controlled trials (RCTs) of RAS compared with CLS or open surgery in women requiring surgery for gynaecological disease. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.
BACKGROUND: 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. OBJECTIVES: To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease. SEARCH METHODS: 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. SELECTION CRITERIA: Randomised controlled trials (RCTs) of RAS compared with CLS or open surgery in women requiring surgery for gynaecological disease. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.
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