The safety and effectiveness of Da Vinci surgical system compared with open surgery and laparoscopic surgery: a rapid assessment

Transcription

1 Journal of Evidence-Based Medicine ISSN REVIEW ARTICLE The safety and effectiveness of Da Vinci surgical system compared with open surgery and laparoscopic surgery: a rapid assessment Jiajie Yu 1,2, Yingqiang Wang 3, Youping Li, *1, Xianglian Li 1, Cuicui Li 4 and Jiantong Shen 5 1 Chinese Cochrane/Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, , China 2 West China Medical School, Sichuan University, Chengdu, , China 3 The 363rd hospital, Aviation Industry Corporation of China, Chengdu, , China 4 The Nuclear Industry 416th Hospital, Chengdu, , China 5 The Medical school of Huzhou teachers college, Huzhou, , China Keywords Da Vinci surgical system; effectiveness; rapid assessment; safety. Correspondence Youping Li, The Chinese Evidence-based Medicine Center/The Chinese Cochrane centre, West China Hospital, Sichuan University, No. 37, Guoxue Xiang, Chengdu China, , China. Tel: ; Fax: ; yzmylab@hotmal.com Received 20 September 2014; accepted for publication 14 April doi: /jebm Abstract Objective: The primary objectives of this rapid assessment were to assess the clinical evidence of Da Vinci surgical system (DVSS) comparing with open procedures and laparoscopic procedures, and in order to provide the evidence for health decision makers and clinician. Methods: A comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and Wanfang) and HTA websites were completed up to 9 October, Two reviews (Jiajie Yu and Yingqiang Wang) independently extracted data of the manuscripts, and assessed quality of included studies using AMSTAR tools. Qualitative description and GRADE were used to report the outcomes and evidence quality. Outcomes: A total of 17 studies were included: 3 were HTA and 14 were SR/metaanalysis. The included studies focused on prostatectomy, nephrectomy, hysterectomy colorectal surgery, and cardiac surgery. DVSS was shown to be associated with statistically significant reduction in length of hospital stay, blood loss, and transfusion rate compared with open and laparoscopic surgery, but increase in operative time when compared with open surgery. Conclusion: Based on the evidence included in this rapid assessment, DVSS has a limited impact on several clinical outcomes. Considering no available data from randomized controlled trials and much higher cost, decisions will be complex and need to be made carefully. Decision makers should cut down the quantity of purchasing and reasonable allocate them. Introduction Minimally invasive surgery refers to surgeons performing surgical procedures with laparoscopy or other modern medical techniques. Surgical robot is one of minimally invasive surgical technologies (1). Da Vinci Surgical System (DVSS) is the most widely marked and studied surgical robot in recently years. It is a master slave telemanipulation, in which the master direct three or four robotic surgical arms from a computervideo console. The DVSS may result in reduction of blood loss, fewer complications, postoperative pain, shorter hospital stays and shorter recovery times comparing with the traditional open and laparoscopic techniques (2). Considering these advantages, it has generated considerable interest from clinicians and patients. Given the recent introduction and increasing diffusion of robot-assisted surgery with Da Vinci System and its high capital and operating costs, a review of the clinical and economic impact was needed to inform decision-makers its acquisition JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 121

2 A rapid assessment of Da Vinci surgical system J. Yu et al. and potential use (3). The primary objective of this rapid assessment was to assess the clinical and cost-effectiveness of DVSS comparing with open procedures and laparoscopic procedures from the government s perspective, in order to assist decision-makers in formulating their evidence-based recommendations. Methods Study selection We included health technology assessment, systematic review or meta-analysis; recruited individuals operated by DVSS; assessed the effect of robotic surgery used by DVSS comparing with open or laparoscopic procedure. Predefined outcomes included: (1) effectiveness: hospital stay; operative time and health-related quality of life; (2) safety: mortality; blood loss; incident of transfusion; conversion rate; reduction of pain and complication. Data sources and searches The following bibliographic databases were retrieved: EMbase, PubMed, The Cochrane Library, Web of science, CNKI, WanFang, VIP until 9 October The search strategy included Mesh and keywords, including Da Vinci, Da Vinci surgical system, robotic surgery, robot-assisted surgery, robot-assisted laparoscopic surgery, computer-assisted laparoscopic surgery, systematic review, meta-analysis, literature review, health technology assessment, and economical analysis. The languages were limited to English and Chinese languages. Other Internet search engines were used to search for additional information (e.g., International Network of Agencies for Health technology assessment, Canadian Agency for Drugs and Technologies in Health, Institute for Clinical Evaluation Science and other institution of Health technology assessment). Data extraction Two reviews (Jiajie Yu and Yingqiang Wang) independently screened the titles and abstracts to identify articles that met the inclusion criteria, and then independently evaluated the full texts of the selected articles. Disagreements were resolved through discussion until consensus was reached. A well-designed form was used to extract all relevant characteristics and outcomes from the included studies. Two reviews (Jiajie Yu and Yingqiang Wang) independently extracted data, the disagreement were resolved through discussion. Quality assessment Two reviewers (Jiajie Yu and Yingqiang Wang) independently assessed the quality of included studies, the disagreement were resolved through discussion. We consulted the checklist of HTA to assess the quality of HTA for no consensus evaluation tool for HTA (4). The AMSTAR was used to assess the quality of systematic review/meta-analysis (5). Data analysis We took a qualitative presentation of each study for the pooling method was inappropriate in this study. Results The characteristics of included studies A total of 272 records were obtained after systematically searched the database and relevant websites. After screening titles and abstracts, 50 documents including 23 systematic reviews/ meta-analysis and 27 HTAs were identified. In addition, 29 were excluded after reviewing the full texts. Finally, 21 articles published between 2006 and 2012 were included (7) (HTAs and 14 SR/meta-analyses) (Figure 1). Of the seven HTA reports (n = 32,499), four were published by a same author in Spanish, two published by Canadian Agency for Drugs and Technologies in Health (CADTH) in 2008 and 2011 respectively, the last one was published by ASERNIP- S from Australia. These HTA reports interested in different diseases, these review assessed interventions about prostatectomy, nephrectomy, hysterectomy, coronary artery bypass graft and fundoplication. Of 14 systematic reviews/metaanalysis involving eight countries (n = 13,017), five studies assessed the outcomes of colorectal disease, two studies focused on gynecological disease and prostatic carcinoma, one reported ureteropelvic junction obstruction, endometriosis, obesity, and fundoplication, respectively. The characteristics of included studies are listed in Tables 1 and 2. Quality assessment Results of the quality assessment in SR/meta-analyses are present in Table 3. Of 14 systematic reviews/meta-analysis, 2 articles with level A showed low risk of bias, 8 articles with level B showed moderate risk of bias, 4 articles with level C showed high risk of bias. Of three HTA, one study was high quality and the other two studies were moderate quality. Safety and effectiveness in HTA Prostatectomy DVSS on prostatectomy were reported in three HTAs (n = 11,728) (6 8). These studies indicated that DVSS was associated with significantly longer operative time, shorter length of hospital stay, reduced blood loss and lower transfusion rate comparing with open prostatectomy. Furthermore, DVSS 122 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

3 J. Yu et al. A rapid assessment of Da Vinci surgical system Included Eligibility Screening Iden fica on 251 records were identified through databases searching: CNKI (n=0), Web of science (n=81), VIP (n=0), The Cochrane library (n=59), CBM (n=0), EMbase (n=34), WanFang (n=0) and PubMed (n=77) 199 records were screened after duplicates removed 50 full text articles were assessed for eligibility 21 articles were included for quality assessment 21 records identified through websites sources searching: International Network of Agencies for Health technology assessment (INAHTA) (n=20), Canadian Agency for Drugs and Technologies in Health (CADTH) (n=1) 149 records were excluded after checking titles and abstracts 29 full text articles were excluded, with reasons:. 12 articles written other than English. 10 articles had no outcomes of interest. 5 articles reported in protocol. 2 article were econometric model Figure 1 Flow chart of studies selection. was associated with a significantly shorter operative time and length of hospital stay comparing with traditional laparoscopic prostatectomy, it also had significantly reduction in blood loss, transfusion rate and complication rate (Table 4). Nephrectomy DVSS on nephrectomy were reported in two HTAs (n = 877) (6, 8). A longer operative time, shorter length of hospital stay and lower complication rate was found when comparing DVSS with open prostatectomy. Moreover, DVSS was associated with significantly longer operative time, shorter length of hospital stay but higher complication rate comparing with laparoscopic prostatectomy. All studies showed that DVSS had a reduction in blood loss (Table 5) Hysterectomy Only one HTA reported the outcomes of hysterectomy (8). DVSS was associated with significantly longer operative time, shorter length of stay, lower blood loss, transfusion rate, and complication rate comparing with traditional open and laparoscopic hysterectomy (Table 6). Coronary artery bypass grafting Studies from cardiac procedures are scarce and most of them were coronary artery bypass grafting (6, 7). We also found longer operative time, shorter length of stay, lower complication rate comparing DVSS with control (Table 7). Fundoplication Only one HTA reported the outcomes of fundoplication (7). We listed all including studies in this study for a high degree of heterogeneity among them. However, these studies showed no sufficient data to confirm potential benefits of DVSS (Table 8). Safety and Effectiveness in SR/Meta-Analyses Rectal/colorectal/colonic disease We identified three studies with 2227 patients regarding rectal/colorectal/colonic disease (24, 25, 28). There is no significantly differences between DVSS and traditional laparoscopic surgery on operative time, length of stay, and JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 123

4 A rapid assessment of Da Vinci surgical system J. Yu et al. Table 1 The characteristics of the included HTA Study n Country Comparison Study Outcomes Conclusion ASERNIP-S, 2004 (3) 1541 Australia C1; C2 ➀➃➄➅ i ii I III IV DVSS was associated with a significantly reduced lengths of hospital stay and blood loss compared with C1; DVSS has no significant difference comparing with C2. CADTH, 2008 (4) 4945 Canada C1; C2 ➀➁➂ i ii I III IV DVSS may have some clinical benefit over other methods in prostatectomy; however, this finding is based largely on observational data. CADTH, 2011 (5) Canada C1; C2 ➃ i ii iii I II III DVSS have an impact on several clinical outcomes, the benefit vary between indications. Available evidence is limited; decisions about the uptake of robot-assisted surgery will be complex and need to be made carefully. Llanos Méndez, 2010 (6) (cardiovascular surgery) Llanos Méndez, 2010 (7) (general and digestive surgery) Llanos Méndez, 2010 (8) (hysterectomy) Llanos Méndez, 2010 (9) (prostatectomy) Spanish C1; C2 ➄➆ i ii III No sufficient data to confirm potential benefits in terms of effectiveness and safety of the robotic surgery comparing with conventional laparoscopic or open surgery. Spanish C2 ➆➇ i ii iii III No statistically significant differences were found in the duration of the intervention, the average recovery time of intestinal function and hospital stay. Postoperative complications were greater among those interventions and conventional laparoscopy. Spanish C1; C2 ➄➅➇ i I No sufficient data to confirm potential benefits in terms of effectiveness and safety of the robotic surgery comparing with conventional laparoscopic or open surgery. Spanish C1; C2 ➈ ii iii I DVSS have less blood loss, shorter hospital stays, lower average scores on the Likert pain scale and a shorter period for the recuperation of continence and sexual function comparing with conventional laparoscopic or open surgery Comparison: C1 open surgery; C2 laparoscopic surgery Study design: ➀ RCT; ➁ Meta-analysis; ➂ SR; ➃ Clinical controlled studies; ➄ Case series; ➅ Case report; ➆ Cohort studies; ➇ Recommendation; ➈ NR Effectiveness outcomes: i operative time; ii length of hospital stay; ii others (e.g., pain, the number of lymph nodes, sexual competence) Safety outcomes: I Blood loss; II Transfusion rate; III Complication rate; IV Conversion rate complication rate in rectal disease. However, DVSS was associated with a significant lower blood loss. Comparisons of DVSS and laparoscopic surgery in Malignant colorectal disease for the outcomes of operative time, length of stay, and blood loss favored DVSS. There were also no significantly differences between DVSS and traditional laparoscopic surgery on operative time, length of stay, blood loss, and complication rate in colonic disease (Table 9). 124 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

5 J. Yu et al. A rapid assessment of Da Vinci surgical system Table 2 The characteristic of the included SR/ Meta-analysis Study Country Disease Study n/n Comparison Outcomes Conclusion AlAsari 2012 (12) Korean Colorectal cancer SR 1681 (41) C1 ➀➁➂; I III IV Safe and feasible option in colorectal surgery and a promising field; however, further prospective randomized studies are required. Antioniu 2012 (13) Germany Rectal cancer SR 1031 (39) C1 ➀➁; I III IV Feasible applications in colorectal surgery. Further studies are required to evaluate its oncologic and patient-oriented outcomes. Braga 2009 (14) Canada Ureteropelvic junction obstruction SR/ Meta 326 (8) C2 ➀➁; III DVSS and C2 appear to be equivalent with regard to postoperative urinary leaks, hospital readmissions, success rates, and operative time. Carvalho 2012 (15) American Endometriosis SR 81 (4) C1 ➀; I III IV Feasible even in severe endometriosis cases without conversion. Lack of long-term outcome studies, and RCTs are necessary. EI-Hakim 2006 (16) American Prostate cancer SR 4679 (18) C1;C2 ➀➂; I III IV V Promising surgical approach for men with localized prostate cancer. Short-term clinical and pathological results compare favorably to conventional laparoscopic surgery. Ficarra 2007 (17) Italian Prostate cancer SR (8) 8 C1;C2 ➀➁➂; I III IV Short learning curve and interesting postoperative results, especially with regard to continence recovery. The available data on recovery of erectile function and oncologic follow-up are still incomplete Gill 2011 (18) Canada Adiposis SR 1253 (22) C1 ➀➁➂; III IV Safe and feasible option for severely obese patients Kanji 2011 (19) Canada Colorectal cancer SR 854 (20) C1 ➀➁; III IV V Safe and feasible option in colorectal surgery Liu 2012 (20) China Gynecological disease SR 158 (2) C2 ➀➁➂; I III IV V Limited evidence showed that robotic surgery did not benefit women with benign gynecological disease in effectiveness or in safety. Memon 2012 (21) Australia Rectal cancer Meta 754 (7) C2 ➀➁; III IV DVSS decreased the conversion rate compared with conventional laparoscopic surgery. Other clinical outcomes and oncologic outcomes were equivalent. Ortiz-Oshiro 2012 (22) Spanish Rectal cancer SR/ Meta 486 (5) C2 ➀➁➂; I IV V Conversion to open rate may be reduced compared with conventional laparoscopic surgery Wang 2012 (23) China Gastroesophageal reflux Weinberg 2011 (24) American Gynecological disease Meta 221 (6) C2 ➀➂; III Clinical outcomes were comparable, but DVSS prolonged the operation time. SR (33) 8 C1;C2 ➀➁;I III IV DVSS have less blood loss, shorter hospital stays, lower pain and less complication comparing with conventional laparoscopic or open surgery. However, further prospective randomized studies are required Yang 2012 (25) China Rectal cancer Meta 1493 (16) C2 ➀➁➂; I III IV Robotic colorectal surgery is a promising tool, especially for patients with rectal cancer Comparison: C1 open surgery; C2 laparoscopic surgery. Effectiveness outcomes: ➀ operative time; ➁ length of hospital stay; ➂ others (e.g., pain, the number of lymph nodes, sexual competence). Safety outcomes: I Blood loss; II Transfusion rate; III Complication rate; IV Conversion rate. JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 125

6 A rapid assessment of Da Vinci surgical system J. Yu et al. Table 3 Quality assessment of SR/meta-analysis (AMSTRA) AMSTRA Checklists Study Item 1 Item 2 Item 3 Item 4 Item 5 Item 6 Item 7 Item 8 Item 9 Item 10 Item 11 Total Level AlAsari 2012 (15) Can t answer Can t answer Yes Yes No Yes No No No No No 3 C Antioniu 2012 (16) Can t answer Yes No No No Yes No No No No Yes 3 C Braga 2009 (17) Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes 10 A Carvalho 2012 (18) Can t answer Yes Yes Yes No Yes No No No No No 4 B EI-Hakim 2006 (19) Can t answer Can t answer No No No Yes No No No No No 1 C Ficarra 2007 (20) Can t answer Can t answer Yes Yes No Yes No No No No Can t answer 3 C Gill 2011 (21) Can t answer Yes Yes Yes No Yes No Yes No No Yes 6 B Kanji 2011 (22) Can t answer Yes Yes Yes No Yes Yes No No No No 5 B Liu 2012 (23) Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 11 A Memon 2012 (24) Can t answer Yes Yes Yes No Yes Yes Yes Yes No No 7 B Ortiz-Oshiro 2012 (25) Can t answer Yes Yes Yes No Yes Yes Yes Yes No No 7 B Wang 2012 (26) Can t answer Yes Yes Yes No Yes Yes Yes Yes No No 7 B Weinberg 2011 (27) Can t answer Can t answer Yes Yes No Yes No Yes No No No 4 B Yang 2012 (28) Can t answer Yes Yes Yes No Yes Yes Yes Yes Yes Can t answer 8 B Notes: 11 items in AMSTRA checklist; Yes = 1; No or Can t answer = 0. Level A 8; 4 level B <8; level C < 4. Table 4 Clinical outcomes from prostatectomy in HTA Operative time (minutes) Hospital stay (days) Conversion rate Incident of complication Blood loss (ml) Incident of transfusion Studies Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes ASERNIP-S 2004 (6) CADTH 2008 (7) CADTH 2011 (8) CADTH 2008 (7) CADTH 2011 (8) RARP vs. ORP RARP vs. ORP RARP vs. ORP RARP vs. LRP RARP vs. LRP 1 (60) 288 vs (60) 1.5 vs (60) 6.7% vs. 0.3% 1 (60) 23% vs. 37% 13 (3573) 222 vs (3573) 1.4% vs. 13 (3573) 8.3% vs. 10.3% 19 (5201) (5554) (5662) 0.73 (0.54, (17.13, 58.34) b ( 2.13, 0.94) b 15 (1479) 222 vs (1479) 1.1% vs. 1.4% 9 (1415) ( 44.36, 1.22) b 15 (1479) 8.3% vs. 10.3% 7 (1235) (1845) 0.85 (0.50, ( 1.33, 0.27) b 1 (60) 329 vs (60) 6.7% vs. 30% 13 (3573) 231 vs (3573) 3.9% vs. 24% 1.00) c ( , ) b 0.30) c 21 (5568) ( (0.14, 15 (1479) 231 vs (1479) 3.9% vs. 8.4% 1.44) c ( , 21.49) b 0.94) c 10 (1655) (1820) 0.54 (0.31, RARP, robot-assisted radical prostatectomy; ORP, open radical prostatectomy; LRP, laparoscopic radical prostatectomy;, not reported. a Number of including studies (simple size). b WMD and 95%CI. c RR and 95%CI. 126 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

7 J. Yu et al. A rapid assessment of Da Vinci surgical system Table 5 Clinical outcomes for nephrectomy from HTA Operative time Hospital stay Incident of Blood loss Incident of Warm ischemic (minutes) (days) complications (ml) transfusion time (minutes) Studies Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes ASERNIP-S 2004 (6) ASERNIP-S 2004 (6) CADTH 2011 (8) RALLDP vs. LLDP RALLDP vs. OLDP RAPN vs. LPN 1 (33) 166 vs (33) 1.9 vs (33) 8% vs. 4% 1 (33) 68 vs. <100 1 (37) 166 vs (37) 1.9 vs (37) 4% vs. 16% 1 (37) 68 vs. >100 9 (717) 1.42 ( 15.78, 9 (717) ) b ( 0.47, 0.03) b 6 (611) 1.24 (0.79, 9 (717) ) b ( 53.63, 18.75) b 4 (434) 0.85 (0.24, 8 (658) 4.18 ( 8.17, 3.09) b 0.18) b CADTH 2011 (8) CADTH 2011 (8) RARN vs. LRN RARN vs. ORN 2 (66) 221 vs (66) 3.5 vs (66) 20% vs. 13% 2 (66) 210 vs (66) 20% vs. 13% 345 vs vs vs % vs. 17% 1 (24) 345 vs (24) 3 vs. 5 1 (24) 16% vs. 16% 1 (24) 125 vs (24) 16% vs. 16% RAPN, robot-assisted partial nephrectomy; LPN, laparoscopic partial nephrectomy; ORN, open radical nephrectomy; RALLDP, robotic-assisted laparoscopic live-donor nephrectomy; LLDP, laparoscopic live-donor nephrectomy; OLDP, open live-donor nephrectomy;, not reported. a Number of including studies (simple size). b WMD and 95%CI. c RR and 95%CI. JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 127

8 A rapid assessment of Da Vinci surgical system J. Yu et al. Table 6 Clinical outcomes from hysterectomy in HTA Incident of Incident of Operative time (minutes) Hospital stay (days) complications Blood loss (ml) transfusion Studies Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes CADTH 2011 (8) RARH vs. ORH (40.91, 86.22) b ( , (1561) (40.91, 86.22) b (1335) 2.21) b (1345) (0.27, 0.52) c (1450) ) b (1025) (0.15, 0.41) c CADTH 2011 (8) RARH vs. LRH ( 0.38, ( 78.37, (1314) ( 7.95, 30.87) b (1080) 0.06) b (389) (0.31, 0.95) c (1080) 43.54) b (595) (0.26, 1.49) c RARH, robot-assisted radical hysterectomy; ORH, open radical hysterectomy; LRH, laparoscopic radical hysterectomy. a Number of including studies (simple size). b WMD and 95%CI. c RR and 95%CI. Table 7 Clinical outcomes from coronary artery bypass grafting in HTA Operative time (minutes) Hospital stay (days) Incident of complications ICU stay (hours) Studies Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes ASERNIP-S 2004 (6) MIDCAB vs. CMIDCAB 1 (95) 8.9 vs (95) 16.3 vs ASERNIP-S 2004 (6) MIDCAB vs. CCABG 1 (117) 8.9 vs (117) 16.3 vs CADTH 2008 (7) RACABG vs. CABG 1 (200) 348 vs (200) 3.77 vs (200) 24% vs. 57% CABG, coronary artery bypass grafting; MIDCAB, robotic minimally invasive direct coronary artery bypass; CMIDCAB, conventional MIDCAB; CCABG, conventional coronary artery bypass grafting;, not reported. a Number of including studies (simple size). 128 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

9 J. Yu et al. A rapid assessment of Da Vinci surgical system Table 8 Clinical outcomes fundoplication in HTA (RAF vs. LP) Studies n Operative time (minutes) Hospital stay (days) Incident of complication Blood loss Giulianotti vs vs % vs. 11.4% Melvin vs % vs. 80% Draaisma vs. 28% Morino vs El Nakadi vs % vs. 36% Müller-Stich % vs. 10% RAF: robotic-assisted fundoplication; LP: Laparoscopic fundoplication;, not reported. Prostate cancer The clinical outcomes of including articles had been discussed in HTA before (19 20). There is no significant differences in operative time between DVSS and laparoscopic surgery, but favored DVSS in blood loss and incident of complication (Table 10). Gynaecological disease Two studies, involving 246 patients, reported the outcomes on gynaecological disease. DVSS was associated with a significantly longer operative time, longer length of stay, and lower incident of complications comparing with traditional laparoscopic surgery, no significant difference was found in conversion rate (Table 11). Other diseases Four other diseases were reported in four studies, respectively. DVSS was associated with significantly shorter operative time and length of stay comparing with laparoscopic surgery on ureteropelvic junction obstruction. No significant difference was found in gastroesophageal reflux disease. The other two studies only reported the outcomes of DVSS without control (Table 12). Summary of findings Summary of findings in HTA Overall, DVSS could significantly reduce blood loss and transfusion rate and blood loss, however, the hospital stay and incident of complications were uncertainty. Considering the limited number of including studies and low quality, decision makers should weighed the pros and cons and make final decisions based on local condition (Table 13). Summary of findings in SR/Meta-analyses Overall, the effectiveness and safety indications vary among different diseases. At the same time, all of included studies were observational studies with low quality. Discussion A classic health technology assessment should assess technical characteristics, clinical effectiveness, safety, economics, social and ethical considerations. HTA is based on a systematic scientifically base work method which can be time consuming as well as resource consuming. However, we were required to complete the current assessment in two months by National Heath and Family Planning Commission. It was impossible to collect and evaluate all relevant evidence in such a short time. Therefore, we collected health technology assessment and systematic review/meta-analyses which were the highest level of evidence. The economics, social and ethics outcomes would be reported in other article. The main effectiveness outcomes were operative time and length of hospital stay; the safety outcomes were incidence of complications, blood loss, transfusion rate and conversion rate. However, the results showed that the clinical outcomes vary between diseases. They primarily reported the outcomes of prostatectomy, nephrectomy, hysterectomy, and colorectal surgery. No sufficient data to confirm potential benefits of the robotic surgery compared with conventional laparoscopic or open surgery about other diseases. There were some differences in the priorities between HTA and SR/meta-analysis, HTA provided the evidence to health decision-makers which focused on the clinical and economic outcomes, especially the economic outcomes. SR provided clinicians with evidence which primarily identify clinical safety and effectiveness. Considering that, we respective reported the outcomes according to different study designs. Limitations This study also has some limitations. First, this review was lack of prospective RCTs, the included HTA and SR were mostly based on observational study which quality was lower than RCTs. However, considering the difficulties to imply randomization and blind in the surgical procedures, nonrandom studies and observational studies were also essential evidence from a feasible and transformative perspective. Second, many outcomes showed heterogeneity across studies JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 129

10 A rapid assessment of Da Vinci surgical system J. Yu et al. Table 9 Clinical outcomes form rectal/ colorectal/ colonic disease in SR/ Meta-analysis (RALS vs. CLS) Operative time Hospital stay Blood loss Conversion Incident of (minutes) (days) (ml) rate complications Study Disease N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes Memon 2012 (24) Colorectal cancer Ortiz-Oshiro 2012 (25) Colorectal cancer Yang 2012 (28) Colorectal cancer Yang 2012 (28) Colorectal disease 7 (752) 2.96 ( 0.12, 0.01) b 3( ) 0.57 ( 1.83, 0.69) b 7 (752) 7% ( 1%, 1( ) 0.93 (0.67, 1.29) d 12%) c 5 (486) 6.03 ( 10.77, 1.28) b 5 (486) 0.06 ( 2.38, 2.26) ND 5 (488) 0.31 (0.12, 5 (422) ND f 0.78) e 7 (720) ( 10.73, 41.94) b 5 (495) 0.07 ( 0.79, 0.93) b 3 (270) ( 65.76, 7 (726) 0.07 ( 0.13, 28.75) b 5 (269) (18.49, 51.36) b 4 (242) 0.46 ( 0.82, 0.10) b 5 (269) 17.7 ( 34.16, 3 (213) 0.01 ( 0.05, 1.23) b Anastomotic leakage: 1.12 (0.49, 2.56) d 0.00) c 7 (726) 1.07 (0.73, 1.56) de Anastomotic leakage: 0.01 ( 0.03, 0.05) c Incident of wound infection: 0.00 ( 0.03, 0.04) c Incident of Bowel obstruction: 0.01 ( 0.02, 0.04) c 0.08) bf 0.94 (0.71, 1.26) de ( 1.17, 44.49) ag Anastomotic leakage: 0.01 ( 0.02, 0.03) c 0.67 ( 1.75, 0.42) ag Incident of wound infection: 0.01 ( 0.04, 0.02) c 5 (269) 0.03 ( 0.04, 60.5 (47.78, 72.71) af Yang 2012 (28) Colonic disease 5 (269) (34.63, 67.06) b 4 (242) 0.03 ( 0.66, 0.59) b 5 (269) 3.53 ( 18.00, 10.93) b Incident of Bowel obstruction: 0.00 ( 0.02, 0.03) c 0.09) c 4 (259) 1.12 (0.55, 2.28) de Anastomotic leakage: 0.00 ( 0.05, 0.05) c Incident of wound infection: 0.03 ( 0.1, 0.04) c Incident of Bowel obstruction: 0.02 ( 0.09, 0.06) c RALS, robot-assistant laparoscopic surgery; CLS, conventional laparoscopic surgery;, not reported. a Number of including studies (simple size). b MD and 95%CI. c RD and 95%CI. d RR and 95%CI. e OR and 95%CI. f Intraoperative complications. g Benign colorectal disease. h Malignant colorectal disease. ipostoperative complications. 130 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

11 J. Yu et al. A rapid assessment of Da Vinci surgical system Table 10 Clinical outcomes from prostatectomy in SR/Meta-analysis Operative time Operative time Blood loss Conversion Incident of (minutes) (days) (ml) rate complications Mortality Study Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes EI-Hakim 2006 (19) RP vs. RRP/LP 10 (373) RP: (373) RP: (373) RP: 1.1% 10 (3730) Overall/major complication 10 (3730) RP: 0 5 (1106) LP: (1106) LP: (1106) LP: 1.4% 5 (1106) RP: 8.3%/3.8% 5 (1106) LP: 0 3 (3200) RRP: (3200) RRP: (3200) RRP: 3 (3200) LP: 16.8%/4.9% 3 (32000) RRP: 0.04 RRP: 10.3%/4.0% Ficarra 2007 (20) RALP 14 (2272) (2272) (2272) (2272) 0 2% 14 (2272) All: 1.5% 17.2% 14 (2272) Urine leaks: 1.8% Ileus: 0.8% Bladder-neck stenosis: 7.4% RP, robotic prostatectomy; RRP, radical retropubic prostatectomy; LP, laparoscopic prostatectomy;, Not reported. a Number of including studies (simple size). Table 11 Clinical outcomes from benign gynaecological disease in SR/meta-analysis Operative time (minutes) Hospital stay (days) Blood loss (ml) Conversion rate Incident of complications Study Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes Liu 2012 (23) Benign gynecological diseases 1 (70) 66.0 (40.93, 91.07) b 1 (70) 9.00 ( 3.82, 21.82) b 1 (70) 1.41 (0.22, 9.01) c 1 (70) 2 (0.34, 11.73) cb 5.44 (1.57, 18.82) bd Weinberg 2011 (27) Adnexectomy 1 (176) 77 vs (176) 0 vs. 0 1 (176) 25 vs (176) 0 1 (176) 1.1% vs. 2.2% d, not reported. a Number of including studies (simple size). b MD and 95%CI. c OR and 95%CI. d Intraoperative complications. e Postoperative complications. JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 131

12 A rapid assessment of Da Vinci surgical system J. Yu et al. Table 12 Clinical outcomes from other diseases Operative time (min) Hospital stay (days) Blood loss (ml) Conversion rate Incident of complication Study Disease Intervention N a Outcomes N a Outcomes N a Outcomes N a Outcomes N a Outcomes Braga 2009 (17) Carvalho 2012 (18) Ureteropelvic junction obstruction RAP vs. CLP 7 (305) (273) 0.5 ( 0.6, 5 (181/ ( 24.6, 3) e 0.04) e 145) 0.7 (0.3, 1.6) c Adenomyosis RALS 4 (81) (81) 4 (81) (81) None b ; Colorectal anastomosis dilation: 1 e Gill 2011 (21) Adiposis RALS Restrictive 9 (118) (118) (118) 0 9 (118) None Malaborptive 16 (1165) (1165) (1165) 1.5% 16 Bleeding: 0.6%; (1165) Stenosis/Stricture: 1.1%; Anastomotic leak: 0.7% Wang 2012 (26) Gastroesophageal reflux disease RALF vs. CLF 3 (115) ( 9.57, 3 (54/ 54.75) e 56) 0.81 (0.35, 1.89) bd Dysphagia: 0.83 (0.42, 1.62) d Flatulence: 1.26 (0.58, 2.75) d RALS, robot-assistant laparoscopic surgery; RAP, robot-assistant pyeloplasty; CLP, conventional laparoscopic pyeloplasty; RALF, robotic-assisted laparoscopic fundoplication; CLF, conventional laparoscopic fundoplication;, not reported. a Number of including studies (simple size). b Intraoperative complications. c OR and 95%CI. d RR and 95%CI. e WMD and 95%CI. 132 JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd

13 J. Yu et al. A rapid assessment of Da Vinci surgical system Table 13 Summary findings in HTA Effectiveness Safety Study N (n) Hospital stay Operative time Blood loss Incident of transfusion Incident of complication ASERNIP-S 2004 (3) 67 (1541) Uncertainty Shorten Reduction Reduction Uncertainty CADTH 2008 (4) 19 (4945) Uncertainty Shorten Reduction Reduction Uncertainty CADTH 2011 (5) 95 (26013) Uncertainty Shorten Reduction Reduction Uncertainty Table 14 Summary of findings table in SR/meta-analysis Effectiveness Safety Study N (n) Hospital stay Operative time Conversion rate Blood loss Incident of complications AlAsari 2012 (15) 41 (1681) NC NC NC NC NC Antioniu 2012 (16) 39 (1031) NC NC NC NC NC Braga 2009 (17) 8 (326) Shorten Shorten NR NR ND Carvalho 2012 (18) 4 (81) NC NC NC NC NC EI-Hakim 2006 (19) 18 (4679) Uncertainty NR ND Reduction Reduction Ficarra 2007 (20) 8 a NC NC NC NC NC Gill 2011 (21) 22 (1253) NC NC NC NC NC Kanji 2011 (22) 20 (854) NC NC NC NC NC Liu 2012 (23) 2 (158) ND Increasing ND NR Increasing Memon 2012 (24) 7 (754) ND NR ND ND ND Ortiz-Oshiro 2012 (25) 5 (486) ND Shorten Reduction ND ND Wang 2012 (26) 6 (221) ND NC NR NR ND Weinberg 2011 (27) 33 a Uncertainty Uncertainty ND Uncertainty Uncertainty Yang 2012 (28) 16 (1493) Shorten Increasing ND Reduction ND NC, no comparison; NR, not reported; ND, no differences. a Did not report the number of participant. because of trial quality, trial design, sample size, definition of outcomes and surgeon experience. Third, the outcomes that were analyzed limited to short-term follow up, while long-term follow up data were unavailable. Conclusion Based on the evidence that was included in this study, the safety and effectiveness of DVSS vary between diseases. After all, DVSS was associated with statistical significantly shorter length of hospital stay, reduced blood loss, lower transfusion rate comparing with traditional open, and laparoscopic surgery. However, high-quality and large simple RCTs and observational study are required to report the long-term outcomes. Given the limitations of the available evidence and uncertainty about the benefits of robot-assisted surgery comparing with alternative approaches, decisions about the uptake of robot-assisted surgery will be complex and need to be made carefully. Reference 1. Da Vinci changing the experience of Surgery. Intuitive Surgical. Available at: 2. Health Information and Quality Authority. Health technology assessment of robot-assisted surgery in selected surgical procedures. Ireland Available at: 3. Barbash GI, Glied SA. New technology and health care costs-the case of robot-assisted surgery. N Engl J Med 2010; 363(8): International Network of Agencies for Health technology assessment. HTA checklist Available at: 5. National Collaborating Centre for Methods and Tools. AMSTAR: assessing methodological quality of systematic reviews. Hamilton, ON: McMaster University Available at: 6. Tooher R, Pham C. Da Vinci surgical robotic system: technology overview (Structured abstract). Available at: LinkFrom=OAI&ID= #.U36s9vlpmhF. 7. Tsakonas E, Nkansah E. The da Vinci surgical robotic system: a review of the clinical and cost-effectiveness (Structured abstract). Available at: CRDWEB/ShowRecord.asp?LinkFrom=OAI&ID= #.Us-zjnDUOrQ JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd 133

14 A rapid assessment of Da Vinci surgical system J. Yu et al. 8. Ho C, Tsakonas E, Tran K, Cimon K, Severn M, Mierzwinski-Urban M, et al. Robot-assisted surgery versus open surgery and laparoscopic surgery: clinical and cost-effectiveness analyses (Project record). Available at: ac.uk/crdweb/showrecord.asp?linkfrom=oai&id= #.Us-zxXDUOrQ. 9. Llanos-Mendez A, Villegas P. Robotic surgery using the da Vinci robotic telemanipulation system in hysterectomy (Structured abstract). Available at: crdweb/showrecord.asp?linkfrom=oai&id= #. Us-zCHDUOrQ. 10. Llanos-Mendez A, Villegas P. Robotic surgery by means of the da Vinci robotic telemanipulation system in general and digestive surgery (Structured abstract). Available at: crd.york.ac.uk/crdweb/showrecord.asp?linkfrom=oai&id= #.Us-z6XDUOrQ. 11. Llanos-Mendez A, Villegas P. Robotic surgery using the da Vinci robotic telemanipulation system in hysterectomy (Structured abstract). Available at: crdweb/showrecord.asp?linkfrom=oai&id= #. Us-0OXDUOrQ. 12. Llanos-Mendez A, Villegas P. Robot-assisted surgery using da Vinci robot telemanipulation in prostatectomy (Structured abstract). Available at: ShowRecord.asp?AccessionNumber= #.Us- 0hnDUOrQ. 13. Balshem H, Helfand M, Schünemann H, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011; 64(4): Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol 2011; 64(12): Alasari S, Min BS. Robotic colorectal surgery: a systematic review. ISRN surgery doi: /2012/ Antoniou SA, Antoniou GA, Koch OO, Pointner R, Granderath FA. Robot-assisted laparoscopic surgery of the colon and rectum. Surg Endosc 2012; 26(1): Braga LHP, Pace K, DeMaria J, Lorenzo AJ. Systematic review and meta-analysis of robotic-assisted versus conventional laparoscopic pyeloplasty for patients with ureteropelvic junction obstruction: effect on operative time, length of hospital stay, postoperative complications, and success rate. Eur Urol 2009; 56(5): Carvalho L, Abrao MS, Deshpande A, Falcone T. Robotics as a new surgical minimally invasive approach to treatment of endometriosis: a systematic review. Int J Med Robotics Comput Assist Surg 2012; 8(2): El-Hakim A, Leung RA, Tewari A. Robotic prostatectomy: a pooled analysis of published literature. Expert REV. Anticancer Ther 2006; 6(1): Ficarra V, Cavalleri S, Novara G, Aragona M, Artibani W. Evidence from robot-assisted laparoscopic radical prostatectomy: a systematic review. Eur Urol 2007; 51(1): Gill RS, Al-Adra DP, Birch D, et al. Robotic-assisted bariatric surgery: a systematic review. Int J Med Robotics Comput Assist Surg 2011; 7(3): Kanji A, Gill RS, Shi X, Birch D, Karmail S. Robotic-assisted colon and rectal surgery: a systematic review. Int J Med Robotics Comput Assist Surg 2011; 7(4): Liu H, Lu D, Wang L, Shi G, Song H, Clarke J. Robotic surgery for benign gynaecological disease. Cochrane Database Syst Rev 2012; 2: CD Memon S, Heriot AG, Murphy DG, Bressel M, Craig Lynch A. Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis. Ann Surg Oncol 2012; 19(7): Ortiz-Oshiro E, Sanchez-Egido I, Moreno-Sierra J, Pérez CF, Díaz JS, Fernández-Represa JA. Robotic assistance may reduce conversion to open in rectal carcinoma laparoscopic surgery: systematic review and meta-analysis. Int J Med Robotics Comput Assist Surg 2012; 8(3): Wang Z, Zheng Q, Jin Z. Meta-analysis of robot-assisted versus conventional laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease. ANZ J Surg 2012; 82(3): Weinberg L, Rao S, Escobar PF. Robotic surgery in gynecology: an updated systematic review. Obstet Gynecol Int Available at: Yang Y, Wang F, Zhang P, et al. Robot-Assisted Versus Conventional Laparoscopic Surgery for Colorectal Disease, Focusing on Rectal Cancer: A Meta-analysis. Ann Surg Oncol 2012; 19(12): JEBM 7 (2014) C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd