ebook img

Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery PDF

298 Pages·2011·2.82 MB·English
by  
Save to my drive
Quick download
Download
Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.

Preview Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery

Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé CADTH Technology Report Issue 137 Robot-Assisted Surgery Compared with Open September 2011 Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses Supporting Informed Decisions Until April 2006, the Canadian Agency for Drugs and Technologies in Health (CADTH) was known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Publications can be requested from: CADTH 600-865 Carling Avenue Ottawa ON Canada K1S 5S8 Tel. 613-226-2553 Fax. 613-226-5392 E-mail: Canadian Agency for Drugs and Technologies in Health Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses 1 Chuong Ho, MD 2 Eva Tsakonas, BA , MSc 1 Khai Tran, MSc , PhD Karen Cimon 1 Melissa Severn, MISt 1 Monika Mierzwinski-Urban, BA, MLIS 3 Jacques Corcos, MD 4 Stephen Pautler, MD , FRCSC September 2011 1 Canadian Agency for Drugs and Technologies in Health, Ottawa, Ontario 2 Consul tant 3 McGill University 4 The University of Western Ontario Reviewers These individuals kindly provided comments on this report. External Reviewers David G. Bell, MD, FRCS(C) Edward D. Matsumoto, MD, MEd Professor and Head, Associate Professor, Department of Urology Department of Surgery Dalhousie University McMaster University Halifax, Nova Scotia Hamilton, Ontario S. Larry Goldenberg, CM, OBC, MD, FRCSC Rick Audas, BBA, MBA, MA, PhD Professor and Head, Associate Professor, Department of Urologic Sciences Faculty of Medicine University of British Columbia Memorial University Vancouver, British Columbia St. John’s, Newfoundland and Labrador Zahra Musa, BSc, MHA Tanya Horsley, BSc, PhD Senior Research Associate, Research Associate, Cancer Care Ontario Centre for Learning in Practice, Toronto, Ontario RCPSC Ottawa, Ontario CADTH Peer Review Group Reviewers Dean A. Fergusson, MHA, PhD Muhammad Mamdani, PharmD, MA, Senior Scientist and Acting Director, MPH Clinical Epidemiology Program Director, AHRC, Ottawa Hospital Research Institute St. Michael’s Hospital Ottawa, Ontario Associate Professor, University of Toronto Toronto, Ontario Industry Minogue Medical Inc. was provided with an opportunity to comment on an earlier version of this report. All comments that were received were considered when preparing the final report. This report is a review of existing public literature, studies, materials, and other information and documentation (collectively, the “source documentation”) that are available to CADTH. The accuracy of the contents of the source documentation on which this report is based is not warranted, assured, or represented in any way by CADTH and CADTH does not assume responsibility for the quality, propriety, inaccuracies, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH takes sole responsibility for the final form and content of this report. The statements and conclusions in this report are those of CADTH and not of its Panel members or reviewers. i Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses Authorship As lead author, Chuong Ho led the project protocol development, supervised the literature review, wrote the draft, revised the report, and prepared the report for publication. Khai Tran and Karen Cimon worked with Chuong Ho to evaluate the articles’ relevance, assess their quality, extract data, perform subgroup analyses of the data, tabulate data for the clinical review, and complete the report. As economic lead for the report, Eva Tsakonas conducted the review of the economic literature, the primary economic evaluation, and the population impact and budget impact analyses. She also researched and wrote the section on planning and implementation, and revised the report based on reviewers’ comments. Stephen Pautler and Jacques Corcos provided clinical expertise and contributed to the draft document and its revisions. Melissa Severn and Monika Mierzwinski-Urban were responsible for designing and executing the literature search strategies, for writing the section and associated appendix on literature searching, and for verifying and formatting the bibliographic references. Acknowledgements The authors are grateful to Krystle Griffin and Pat Reynard for project management support.W e thank Brian Hutton for critical reading of the report and invaluable feedback. Conflicts of Interest None to declare Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: ii Clinical Effectiveness and Economic Analyses EXECUTIVE SUMMARY The Issue Given the recent introduction and increasing diffusion of robotic surgery technology into the prostatectomy, nephrectomy, hysterectomy, and cardiac surgery fields, and its high capital and operating costs, a review of the clinical and economic impact is needed to inform decisions about its acquisition, and potential or expanded use. Objectives The primary objectives of this Health Technology Assessment (HTA) were to assess the clinical and cost-effectiveness of robotic surgery compared with open procedures and laparoscopic procedures. We conducted a systematic review to evaluate the clinical effectiveness of robotic surgery compared with open procedures and laparoscopic procedures, followed by a systematic review of economic evaluation studies. We also conducted a primary economic evaluation of robotic surgery in one indication from a Canadian perspective and assessed robotic surgery’s potential impact on health services (population impact and budget impact) in Canada . Methods A systematic review with meta-analyses was conducted to compare clinical efficacy between robot-assisted, open, and laparoscopic surgeries. The measures of effect for dichotomous data, such as complication rates and positive margin rates, were expressed as risk ratios with 95% confidence intervals (CI). The measures of effect for continuous data, such as operative time and length of hospital stay, were expressed as weighted mean differences with 95% CI. A systematic review of the economic literature was conducted with the aim of assessing the economic evidence on robotic surgery. The primary economic evaluation compared robotic surgery with open surgery and with laparoscopic surgery in the most frequently performed robotic procedure in Canada (radical prostatectomy). Because clinically important between- group differences in effects (as measured using outcomes such as mortality, morbidity, general quality of life, and potential disease recurrence) could not be demonstrated based on the data obtained from the clinical review, only the relative costs of the surgical alternatives were compared in a cost-minimization analysis. This analysis was conducted from the perspective of the publicly funded health care system, and costs were estimated for the length of hospitalization. The population impact analysis estimated the potential number of hospitals in Canada that would be eligible for a robotics program and the number of patients who might be treated. A budget impact analysis was used to estimate the net program costs from an institutional perspective. Clinical Effectiveness During the literature search, 2,031 citations were identified. After the exclusion of articles with irrelevant study designs, populations, interventions, or outcomes, 95 studies were selected for inclusion: 51 on prostatectomy, 26 on hysterectomy, 10 on nephrectomy, and eight on cardiac surgery. A review of the included trials revealed two findings. First, there were no data from randomized controlled trials, and data on nephrectomy and cardiac surgery were limited. Second, based on primary meta-analyses of the included observational studies, robot-assisted surgery was associated with a statistically significant benefit for several clinical outcomes. iii Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses Length of hospital stay: robot-assisted surgery was shown to be associated with statistically significantly reduced lengths of hospital stay compared with open prostatectomy, laparoscopic prostatectomy, open hysterectomy, laparoscopic hysterectomy, and laparoscopic partial nephrectomy. Blood loss and transfusion rates: robot-assisted surgery was associated with a statistically significant reduction in blood loss and transfusion rates compared with open prostatectomy, laparoscopic prostatectomy, and open hysterectomy. Positive margin rates: robot-assisted surgery was associated with a statistically significant reduction of positive margin rates compared with open prostatectomy in pT2 patients (patients whose tumours are confined to the prostate). Incidence of complications: robot-assisted surgery was associated with statistically significant reductions in postoperative complication rates compared with open hysterectomy and laparoscopic hysterectomy. Operative time: robot-assisted surgery was associated with a statistically significantly increased operative time compared with open prostatectomy and open hysterectomy, and a reduced operative time compared with laparoscopic prostatectomy. Findings on robot-assisted cardiac surgery were scarce, but seemed to favour robot-assisted surgery for length of hospital stay. Overall, many of the pooled estimates for comparisons of the selected indications were associated with statistically significant heterogeneity across studies. Subgroup analyses of study outcome data on study quality, study design, and removal of outliers did not show any systematic patterns. An increase in surgeons’ experience was associated with reductions in operative time, length of stay, incidence of complications, and risk of positive margin rates. Given the lack of availability of randomized trials, the presence of unexplained heterogeneity in some pooled estimates, and the occasional identification of studies with conflicting findings, conclusions need to be drawn carefully from meta-analysis. In addition, statistically significant differences favouring robotic surgery were identified for several outcomes, but there is uncertainty about the clinical relevance of the size of these differences. Economic Review and Analysis A systematic review of the economic literature was conducted with the aim of assessing the economic evidence for robotic surgery in terms of study quality, methods, results, and relevance in a Canadian context, and a descriptive approach was used. Thirty economic analyses of the use of robotic surgery were reviewed: 15 on prostatectomy, four on cardiac surgery, two on radical nephrectomy, eight on hysterectomy, and one on multiple indications. The conclusions of the studies varied regarding the costs and cost-effectiveness of robotic surgery, as well as handling and inclusion of costs. Most studies were limited in the reporting of their methods, and one study in hysterectomy was relevant to a current Canadian setting. In the cost-minimization analysis, shorter lengths of stay after robotic radical prostatectomy reduced hospitalization costs relative to open surgery and laparoscopic surgery. However, because of the costs of acquiring, operating, and maintaining the surgical robot, the estimated per-patient costs of the robotic technology were higher than the comparator (incremental costs compared with open surgery are $3,860 per patient and, compared with laparoscopic surgery, Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: iv Clinical Effectiveness and Economic Analyses $4,625 per patient). By increasing the annual caseload, the incremental costs per patient for robotic surgery can be lowered — the mean incremental costs drop significantly during the first 200 procedures. A probabilistic sensitivity analysis suggests that robotic surgery is more expensive than open surgery and laparoscopic surgery in approximately 75% of cases, with cost- saving situations for robotic surgery being largely attributed to variation in hospitalization costs. Health Services Impact The population impact analysis suggests that up to 31 Canadian centres could adopt the robotic technology, assuming the centres that do so have characteristics similar to the centres that already use it. Assuming that their caseloads are similar to those of operational centres, up to 4,030 robotic procedures may be performed in Canada annually. If the number of centres adopting this technology expands to include non-teaching hospitals of a similar bed capacity and hospitals with a smaller bed capacity, the number of patients being treated annually could rise to 11,050. Considering the average patient undergoing a robotic surgical procedure, and the utilization patterns in Canadian robotic centres, the net institutional costs for operating a robotics program with a new da Vinci Si Surgical System for seven years is estimated to be $2.9 million. Cardiac surgery was estimated to be the least costly indication-specific program, with net program costs of $0.9 million over seven years, and prostatectomy was estimated to be the most expensive, with net program costs of $3.5 million over seven years. Conclusions Based on the evidence that was included in this technology assessment, robot-assisted surgery may have an impact on several clinical outcomes in patients undergoing prostatectomy, partial nephrectomy, or hysterectomy. The benefits vary between indications. Findings regarding robot- assisted cardiac surgery were scarce but tended to favour robot-assisted surgery in terms of length of hospital stay. Comparisons between the methods of surgery regarding survival rates and time to return to work were inconclusive due to the scarcity of evidence. Given the limitations of the available evidence and uncertainty about the clinical relevance of the size of benefits of robot-assisted surgery compared with alternative approaches, decisions about the uptake of robot-assisted surgery will be complex and need to be made carefully. Robotically performed surgery is expensive compared with open and laparoscopic approaches. The investment made in acquiring this technology is large, and institutions that choose to adopt this technology need to monitor their costs and outcomes so that they can maximize its cost-effective use in their centre. To decrease costs, centres could maximize caseloads, consider keeping the robot operational for longer, if possible, and use the technology for multiple indications, particularly those with greater potential impact on patient outcomes and institutional cost savings. v Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses TABLE OF CONTENTS EXECUTIVE SUMMARY ...........................................................................................................iii ACRONYMS AND ABBREVIATIONS .......................................................................................ix 1 INTRODUCTION .............................................................................................................. 1 1.1 Background and Setting in Canada .......................................................................................... 1 1.2 Overview of Technology .......................................................................................................... 2 2 ISSUE .............................................................................................................................. 3 3 OBJECTIVES ................................................................................................................... 3 4 CLINICAL REVIEW .......................................................................................................... 4 4.1 Methods ............................................................................................................................. 4 4.1.1 Literature searches ....................................................................................... 4 4.1.2 Selection criteria .......................................................................................... 4 4.1.3 Selection method ......................................................................................... 5 4.1.4 Data extraction strategy ................................................................................ 5 4.1.5 Strategy for validity assessment .................................................................... 5 4.1.6 Data analysis methods .................................................................................. 6 4.2 Results ............................................................................................................................. 6 4.2.1 Quantity of research available ....................................................................... 6 4.2.2 Study characteristics .................................................................................... 6 4.2.3 Data analyses and synthesis ........................................................................ 10 4.3.3 Summary of Findings from Clinical Review ................................................ 46 5 ECONOMIC ANALYSIS ..................................................................................................48 5.1 Review of Economic Studies: Methods ................................................................................. 48 5.1.1 Literature searches ..................................................................................... 48 5.1.2 Selection criteria ........................................................................................ 48 5.1.3 Selection method ....................................................................................... 49 5.1.4 Data extraction strategy .............................................................................. 49 5.1.5 Strategy for validity assessment .................................................................. 49 5.1.6 Data analysis methods ................................................................................ 49 5.2 Review of Economic Studies: Results .................................................................................... 50 5.2.1 Quantity of research available ..................................................................... 50 5.2.2 Study characteristics .................................................................................. 50 5.2.3 Study results .............................................................................................. 57 5.2.4 Summary of economic review .................................................................... 64 5.3 Primary Economic Evaluation: Methods ................................................................................ 66 5.3.1 Type of economic evaluation ...................................................................... 66 5.3.2 Target population ....................................................................................... 68 5.3.3 Comparators .............................................................................................. 68 5.3.4 Perspective ................................................................................................ 68 5.3.5 Effectiveness ............................................................................................. 68 5.3.6 Time horizon ............................................................................................. 68 Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: vi Clinical Effectiveness and Economic Analyses 5.3.7 Modelling ................................................................................................. 68 5.3.8 Resource use and costs ............................................................................... 68 5.3.9 Discount rate ............................................................................................. 70 5.3.10 Variability and uncertainty ......................................................................... 71 5.4 Primary Economic Evaluation: Results .................................................................................. 72 5.4.1 Analysis and results ................................................................................... 72 5.4.2 Results of uncertainty analysis .................................................................... 73 5.4.3 Summary .................................................................................................. 76 6 HEALTH SERVICES IMPACT .........................................................................................77 6.1 Population Impact ................................................................................................................... 77 6.2 Budget Impact ........................................................................................................................ 79 6.3 Planning, Implementation, Utilization, and Legal or Regulatory Considerations .................. 81 6.3.1 Planning and implementation issues ............................................................ 81 6.4 Ethical Considerations ............................................................................................................ 84 6.4.1 Efficiency compared with equity ................................................................. 84 7 DISCUSSION ..................................................................................................................84 7.1 Summary of Results ............................................................................................................... 84 7.2 Strengths and Weaknesses of this Assessment ....................................................................... 88 7.3 Generalizability of Findings ................................................................................................... 89 7.4 Knowledge Gaps .................................................................................................................... 90 8 CONCLUSIONS ..............................................................................................................90 9 REFERENCES ................................................................................................................91 Appendix 1: Canadian Licensing Information for the da Vinci System ........................... 111 Appendix 2: Literature Search Strategy .............................................................................. 115 Appendix 3: Clinical Studies Assessment Form ................................................................ 136 Appendix 4: Flow Chart of Selected Clinical Studies ....................................................... 137 Appendix 5: Excluded Studies for Clinical Review .......................................................... 138 Appendix 6 Study Characteristics .................................................................................... 146 Appendix 7: Additional Study and Patient Characteristics ............................................... 164 Appendix 8: Patient Characteristics .................................................................................... 193 Appendix 9: Subanalyses of Prostatectomy by Study Design, Study Quality,and Removal of Outliers ......................................................................................... 222 Appendix 10: Subanalyses of Hysterectectomy by Study Design, Study Quality, and Removal of Outliers .................................................................................. 227 Appendix 11: Subanalyses of Nephrectomy by Study Design, Study Quality, and Removal of Outliers ................................................................................. 230 Appendix 12: Economic Review Data Extraction Form ....................................................... 232 Appendix 13: Studies Excluded from the Economic Review.............................................. 233 Appendix 14: Assessment of Quality of Reporting of Studies in Economic Review ...... 234 Appendix 15: Economic Review External Validity Checklist .............................................. 236 Appendix 16: Treatment of Robotic Costs in Studies from Economic Review ................ 237 Appendix 17: Evidence Tables for Economic Review ......................................................... 238 Appendix 18: Undiscounted Per-centre Costs of da Vinci Robot, Maintenance, Consumables, and Training, by Year .................................... 277 vii Robot-Assisted Surgery Compared with Open Surgery and Laparoscopic Surgery: Clinical Effectiveness and Economic Analyses

See more

The list of books you might like

Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.