Robotic-assisted Surgery In Partial Nephrectomy And .
4Evidence Synthesis ProgramRobotic-assisted Surgery inPartial Nephrectomy andCystectomy: A SystematicReviewAugust 2019Prepared for:Department of Veterans AffairsVeterans Health AdministrationHealth Services Research & Development ServiceWashington, DC 20420Prepared by:Evidence Synthesis Program (ESP) CenterWest Los Angeles VA Medical CenterLos Angeles, CAPaul G. Shekelle, MD, PhD, DirectorAuthors:Principal Investigators:Paul G. Shekelle, MD, PhDMelinda Maggard-Gibbons, MDCo-Investigators:Mark Girgis, MDChristopher P. Childers, MD, PhDAmber Tang, BSQiao Ruan, BSMargherita Lamaina, MDResearch Associates:Selene Mak, PhD, MPHMeron Begashaw, MPHMarika S. Booth, MS4
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramPREFACEThe VA Evidence Synthesis Program (ESP) was established in 2007 to provide timely and accuratesyntheses of targeted healthcare topics of importance to clinicians, managers, and policymakers as theywork to improve the health and healthcare of Veterans. These reports help: Develop clinical policies informed by evidence; Implement effective services to improve patient outcomes and to support VA clinical practiceguidelines and performance measures; and Set the direction for future research to address gaps in clinical knowledge.The program is comprised of four ESP Centers across the US and a Coordinating Center located inPortland, Oregon. Center Directors are VA clinicians and recognized leaders in the field of evidencesynthesis with close ties to the AHRQ Evidence-based Practice Center Program and CochraneCollaboration. The Coordinating Center was created to manage program operations, ensuremethodological consistency and quality of products, and interface with stakeholders. To ensureresponsiveness to the needs of decision-makers, the program is governed by a Steering Committeecomprised of health system leadership and researchers. The program solicits nominations for reviewtopics several times a year via the program website.Comments on this evidence report are welcome and can be sent to Nicole Floyd, Deputy Director, ESPCoordinating Center at Nicole.Floyd@va.gov.Recommended citation: Maggard-Gibbons M, Childers CP, Girgis M, Lamaina M, Tang A, Ruan Q,Mak SS. Begashaw M, Booth MS, Shekelle PG, Robotic-Assisted Surgery in Partial Nephrectomy andCystectomy. Los Angeles: Evidence Synthesis Program, Health Services Research and DevelopmentService, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #05226; 2019. Available at: reports.cfm.This report is based on research conducted by the Evidence Synthesis Program (ESP) Center located at the WestLos Angeles VA Medical Center, Los Angeles, CA, funded by the Department of Veterans Affairs, VeteransHealth Administration, Health Services Research and Development. The findings and conclusions in this documentare those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarilyrepresent the views of the Department of Veterans Affairs or the United States government. Therefore, no statementin this article should be construed as an official position of the Department of Veterans Affairs. No investigatorshave any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership oroptions, expert testimony, grants or patents received or pending, or royalties) that conflict with material presentedin the report.i
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramACKNOWLEDGMENTSThis topic was developed in response to a nomination by William Gunnar, MD, for the purposeof understanding the potential benefits and costs or robot-assisted surgery. The scope was furtherdeveloped with input from the topic nominators (ie, Operational Partners), the ESP CoordinatingCenter, the review team, and the technical expert panel (TEP).In designing the study questions and methodology at the outset of this report, the ESP consultedseveral technical and content experts. Broad expertise and perspectives were sought. Divergentand conflicting opinions are common and perceived as healthy scientific discourse that results ina thoughtful, relevant systematic review. Therefore, in the end, study questions, design,methodologic approaches, and/or conclusions do not necessarily represent the views ofindividual technical and content experts.The authors gratefully acknowledge Roberta Shanman, Jon Bergman, and the followingindividuals for their contributions to this project:Operational PartnersOperational partners are system-level stakeholders who have requested the report to informdecision-making. They recommend Technical Expert Panel (TEP) participants; assure VArelevance; help develop and approve final project scope and timeframe for completion; providefeedback on draft report; and provide consultation on strategies for dissemination of the report tofield and relevant groups.Mark Wilson, MDNational Director of Surgery (10NC2)Department of Veterans AffairsWilliam Gunnar, MDFormer National Director of Surgery (10NC2)Department of Veterans AffairsTechnical Expert Panel (TEP)To ensure robust, scientifically relevant work, the TEP guides topic refinement; provides inputon key questions and eligibility criteria, advising on substantive issues or possibly overlookedareas of research; assures VA relevance; and provides feedback on work in progress. TEPmembers are listed below:John Gore, MDAssociate Professor, Adjunct Associate Professor-SurgeryUniversity of WashingtonJim C. Hu, MDProfessor of Urology, Weill Cornell MedicineDirector, LeFrak Center for Robotic Surgeryii
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramMark Jordan, MDChief of UrologyDepartment of Veterans Affairs, Long BeachJohn Leppert, MDAssociate Professor of Urology, Stanford UniversityUrologist at Palo Alto VAJoe Liao, MDProfessor of Urology, Stanford UniversityVA Robotic SurgeonMatthew Rettig, MDMedical Director, Prostate Cancer Program of the Institute of Urologic Oncology, UCLAProfessor, Division of Hematology-Oncology and Department of Urology, UCLAKevin Win, MDStaff Anesthesiology, Department of Veterans AffairsPeer ReviewersThe Coordinating Center sought input from external peer reviewers to review the draft report andprovide feedback on the objectives, scope, methods used, perception of bias, and omittedevidence. Peer reviewers must disclose any relevant financial or non-financial conflicts ofinterest. Because of their unique clinical or content expertise, individuals with potential conflictsmay be retained. The Coordinating Center and the ESP Center work to balance, manage, ormitigate any potential nonfinancial conflicts of interest identified.iii
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramTABLE OF CONTENTSACKNOWLEDGMENTS . IIEXECUTIVE SUMMARY . 7Introduction . 7Methods. 7Data Sources and Searches . 8Study Selection . 8Data Abstraction and Quality Assessment . 8Data Synthesis and Analysis . 8Results . 8Results of Literature Search . 8Summary of Results for Key Questions. 8Discussion . 10Key Findings and Strength of Evidence . 10Applicability . 10Research Gaps/Future Research . 10Conclusions . 10Abbreviations Table . 11EVIDENCE REPORT . 12INTRODUCTION. 12METHODS . 13Topic Development . 13Search Strategy . 13Study Selection . 13Data Abstraction . 14Quality Assessment . 14Data Synthesis. 14Rating the Body of Evidence . 14Peer Review . 15RESULTS . 16Description of the Evidence . 16iv
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramKey Question 1A – Cystectomy: What is the clinical effectiveness of robotic-assistedsurgery compared to open surgery or conventional laparoscopic surgery for cystectomy? . 18Summary of Findings. 24Certainty of Evidence for Key Question 1A . 24Key Question 1B – Cystectomy: What is the cost effectiveness of robotic-assistedsurgery compared to open surgery or conventional laparoscopic surgery for cystectomy? . 25Summary of Findings. 26Certainty of Evidence for Key Question 1B . 27Key Question 2A – partial nephrectomy: What is the clinical effectiveness ofrobotic-assisted surgery compared to open surgery or conventional laparoscopicsurgery for partial nephrectomy? . 27Summary of Findings. 33Certainty of Evidence for Key Question 2A . 33Key Question 2B – Partial nephrectomy: What is the cost effectiveness ofrobotic-assisted surgery compared to open surgery or conventional laparoscopicsurgery for partial nephrectomy? . 34Summary of Findings. 35Certainty of Evidence for Key Question 2B . 35SUMMARY AND DISCUSSION . 36Summary of Evidence by Key Question . 36Key Question 1A: What is the clinical-effectiveness of robotic-assisted surgerycompared to open surgery or conventional laparoscopic surgery for cystectomy? . 36Key Question 1B: What is the clinical-effectiveness of robotic-assisted surgerycompared to open surgery or conventional laparoscopic surgery for partial nephrectomy? . 36Key Question 2A and 2B: What is the cost effectiveness of robotic-assisted surgerycompared to open surgery or conventional laparoscopic surgery for cystectomy andpartial nephrectomy? . 36Limitations . 36Publication Bias . 36Study Quality . 37Heterogeneity . 37Applicability of Findings to the VA Population . 37Research Gaps/Future Research . 37REFERENCES. 39TABLESTable 1. Certainty of Evidence for Cystectomy Studies . 24Table 2. Certainty of Evidence for Partial Nephrectomy Studies . 34v
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramFIGURESFigure 1. Literature Flow Chart . 17Figure 2. Bladder Cancer: Intraoperative Outcomes . 19Figure 3. Bladder Cancer: Postoperative Outcomes . 21Figure 4. Bladder Cancer: Functional/Cancer Outcomes . 23Figure 5. Kidney Cancer: Intraoperative Outcomes . 28Figure 6. Kidney Cancer: Postoperative Outcomes . 30Figure 7. Kidney Cancer: Functional/Cancer Outcomes . 32APPENDIX A. SEARCH STRATEGIES . 42APPENDIX B. PEER REVIEWER COMMENTS AND RESPONSES . 44APPENDIX C. COCHRANE RISK OF BIAS TOOL . 47APPENDIX D. RISK OF BIAS IN NON-RANDOMISED STUDIES – OFINTERVENTIONS (ROBINS-I) . 48APPENDIX E. QUALITY ASSESSMENT FOR INCLUDED RCT STUDIES . 49APPENDIX F. QUALITY ASSESSMENT FOR INCLUDED OBSERVATIONALSTUDIES . 50APPENDIX G. EVIDENCE TABLES . 53APPENDIX H. CITATIONS FOR EXCLUDED PUBLICATIONS . 69vi
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramEVIDENCE REPORTINTRODUCTIONThe robotic surgical platform was introduced in 1999, and by the end of 2017 over 3000 roboticplatforms were installed throughout the United States.4 Urologic surgery was one of the firstsurgical disciplines to adopt the robotic approach, in part because open prostatectomy was amorbid procedure and traditional minimally invasive techniques (laparoscopy) were difficult toapply to this procedure.1,2 As of 2017, over 750,000 robotic procedures are performed each yearin the United States including over 125,000 urologic robotic procedures.Despite the rapid adoption of the approach, there is a growing body of literature questioning theutility of robotic surgery compared to laparoscopic and open surgery. For example, the recentROLARR trial in rectal cancer surgery found no difference between robotic surgery andlaparoscopic surgery for conversion rates, intraoperative and postoperative complications,functional outcomes, or mortality.2 Further, the Laparoscopic Approach to Cervical Cancer(LACC) trial published in 2018 compared minimally invasive surgery, including laparoscopicand robotic, to open surgery in early-stage cervical cancer and found worse survival in theminimally invasive group.5 This recently prompted the FDA to issue a warning stating that “Therelative benefits and risks of surgery using robotically-assisted surgical devices compared toconventional surgical approaches in cancer treatment have not been established.” As a part ofthat statement, the FDA encouraged researchers to study robotic surgery, especially as it relatesto long-term clinical and oncologic outcomes.Further complicating the debate is the economics of the robotic platform. The robotic platformrequires a significant upfront investment, an annual maintenance contract, and ongoinginstrument purchases, not to mention staff and training costs, advertising, and infrastructureupgrade expenses. On the other hand, if the robotic platform can reduce length of stay,complications, readmissions, or improve oncologic outcomes, then these costs may be more thanrecuperated.In light of recent evidence in other surgical disciplines questioning the utility of the roboticplatform, it is important to re-visit the evidence surrounding the use of the robotic platform inurologic surgery, especially for long-term clinical and oncologic outcomes. And while therobotic approach has become the common approach to prostatectomy, there are other urologicprocedures – namely partial nephrectomy and cystectomy – where the introduction of the roboticapproach is still occurring and an evidence synthesis may be useful.To help clinicians, patients, and policymakers make decisions about robotic and other surgicalapproaches in patients undergoing partial nephrectomy and cystectomy, we were asked toconduct a systematic review of benefits and cost effectiveness.12
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramMETHODSTOPIC DEVELOPMENTThis topic was developed in response to a nomination by Dr. Mark Wilson, National Director ofSurgery (10NC2), and Dr. William Gunnar, former National Director of Surgery (10NC2). Keyquestions were then developed with input from the topic nominator, the ESP coordinating center,the review team, and the technical expert panel (TEP).The Key Questions were:KQ1A: What is the clinical effectiveness of robotic-assisted surgery compared to open surgeryor conventional laparoscopic surgery for cystectomy?KQ1B: What is the cost effectiveness of robotic-assisted surgery compared to open surgery orconventional laparoscopic surgery for cystectomy?KQ2A: What is the clinical effectiveness of robotic-assisted surgery compared to open surgeryor conventional laparoscopic surgery for partial nephrectomy?KQ2B: What is the cost effectiveness of robotic-assisted surgery compared to open surgery orconventional laparoscopic surgery for partial nephrectomy?The review was registered in PROSPERO: CRD 42019127413.SEARCH STRATEGYWe conducted searches in PubMed from 1/1/2010-6/29/2019 and Cochrane (all databases) from1/1/2010-6/29/2019. The search used a broad set of terms relating to "robotic surgicalprocedures" or “robotic-assisted”, "cystectomy" or "nephrectomy", and "cost-effectiveness".Prior to 2010, robotic procedures were not widely being performed and many surgeons were stillin the so-called "learning curve". As such, our technical expert panel considered evidence fromstudies published prior to the year 2010 to be insufficiently relevant to modern practice. SeeAppendix A for complete search strategy.STUDY SELECTIONFour team members working in pairs independently screened the titles of retrieved citations. Fortitles deemed relevant by at least 1 person, abstracts were then screened independently induplicate by 5 team members working in pairs. All disagreements were reconciled through groupdiscussion. Full-text review was conducted in duplicate by 2 independent team members, withany disagreements resolved through discussion. Studies were included at either the abstract orthe full-text level if they were randomized control trials or observational studies comparingrobotic surgery with either laparoscopic or open surgical approaches for either of the includedsurgical procedures. We also included publications of cost-effectiveness models that comparedrobotic surgery with laparoscopic or open surgical approaches. We included all RCTs regardlessof outcomes studied or sample size. To be included, observational studies had to report long-term13
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis Programoncologic outcomes and include at least 80 operations. These thresholds were chosen such thatthe included studies accounted for at least 75% of the total available sample size.DATA ABSTRACTIONData extraction was completed in duplicate. All discrepancies were resolved with full groupdiscussion. We abstracted data on the following: study design, patient characteristics, samplesize, tumor characteristics, intraoperative outcomes, postoperative outcomes (early), long-termfunctional outcomes (including kidney function) and cancer outcomes, duration of follow-up,and data needed for the Cochrane Risk of Bias tool or Cochrane Risk of Bias In Non-randomizedStudies – of Interventions (ROBINS-I).QUALITY ASSESSMENTRandomized controlled trials were assessed for quality (risk of bias) with the Cochrane Risk ofBias tool.6 This tool requires an assessment of whether a study is at high or low (or unknown)risk of bias in 7 domains: random sequence generation, allocation concealment, blinding ofparticipants and personnel, blinding of outcome assessment, incomplete outcome data, selectiveoutcome reporting, and other (See Appendix C for tool; Appendix E for table). We used the Riskof Bias In Non-randomized Studies – of Interventions (ROBINS-I) for observational studies.7This tool requires an assessment of whether a study is at critical, serious, moderate, or low risk ofbias (or no information) in 7 domains: confounding, selection bias, bias in measurementclassification of interventions, bias due to deviations from intended interventions, bias due tomissing data, bias in measurement of outcomes, and bias in selection of the reported result (seeAppendix D for tool; Appendix F for table). Since observational studies are not required to havepublished an a priori protocol, we operationalized the last domain (bias in selection of thereported result) as requiring that studies report the most common variables.DATA SYNTHESISBecause the randomized control trials were too heterogeneous, we did not conduct a metaanalysis of trials. The observational studies were too clinically heterogeneous to support metaanalysis; hence, our synthesis is narrative.RATING THE BODY OF EVIDENCEWe used the criteria of the Grading of Recommendations Assessment, Development andEvaluation (GRADE) working group.8 GRADE assessing the certainty of the evidence based ofthe assessment of the following domains: risk of bias, imprecision, inconsistency, indirectness,and publication bias. This results in categories as follows:High: We are very confident that the true effect lies close to that of the estimate of the effect.Moderate: We are moderately confident in the effect estimate. The true effect is likely to be closeto the estimate of the effect, but there is a possibility that it is substantially different.Low: Our confidence in the effect estimate is limited. The true effect may be substantiallydifferent from the estimate of the effect.14
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramVery low/Insufficient: We have very little confidence in the effect estimate. The true effect islikely to be substantially different from the estimate of effect.PEER REVIEWA draft version of the report was reviewed by technical experts and clinical leadership. Reviewercomments and our response are documented in Appendix B.15
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramRESULTSWe identified 3,877 potentially relevant citations, of which 556 were included at the abstractscreening. From these, a total of 305 abstracts were excluded. Excluded abstracts werecategorized as background/other (n 17), systematic review (n 58), wrong comparison (n 129),wrong procedure (n 40), no long-term outcomes (n 15), and review/editorial (n 46). This left251 publications for full-text review, of which 209 publications were excluded for the followingreasons: sample size 80 (n 84), intervention (n 3), comparison, (n 4), procedure (n 3),follow-up 1 year or unclear cystectomy (n 22), follow-up 3 year or unclear nephrectomy(n 63), no clinical data (n 7), other (n 1), review/editorial (n 16), duplicate (n 4), and full textunavailable (n 2). A full list of excluded studies from the full-text review is included inAppendix H. A total of 42 publications were identified at full-text review as meeting initialinclusion criteria: cost-effectiveness analyses (n 4), cost-only studies (n 4), publicationsdescribing 5 cystectomy RCTs (n 16), cystectomy observational studies (n 11), andnephrectomy observational studies (n 7). See Figure 1 for literature flow. Descriptions ofincluded publications are available in the Evidence Table (Appendix G).DESCRIPTION OF THE EVIDENCEFor cystectomy, 5 studies were RCTs (of note, 2 publications on one study were used to abstractdata for one trial, those being authored by Bochner and colleagues and published in 2014 and2018). Of these, one was a multi-institutional study. These RCTs we judged as being low risk ofbias for intraoperative, early postoperative outcomes, and long-term outcomes. The assigned riskof bias was inherent to the nature of surgical interventions (blinding of intervention and outcomereported not possible). There were 11 observational studies on cystectomy, including 3 multiinstitutional studies. The quality of the observational studies was in general moderate to high riskof bias. Many used propensity modeling which helped balance the comparative arms for patientand tumor characteristics. However, the risk of bias was higher for the long-term outcomes asfollow-up time was lower in the robotic study arms.For partial nephrectomy, 7 observational studies were identified for nephrectomy and judged ashaving low risk of bias in measurement classification of interventions, low risk of bias due tomissing data, and low risk of bias in measurement of outcomes. Bias due to deviations fromintended interventions and bias in selection of the reported result were low to medium. Overall,these studies were most limited by confounding and selection bias and had high to moderate riskof bias.16
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramFigure 1. Literature Flow ChartExcluded: 3,321Total title screened: 3,877Excluded 305 referencesBackground/Other: 17Systematic review: 58Comparison: 129Procedure: 40Outcome: 15Review/editorial: 46Abstracts reviewed: 556Excluded 209 referencesSample size 80: 84Intervention: 3Comparison: 4Procedure: 3Follow up 1yr bladder: 22Follow up 3yr kidney: 63No clinical data: 7Other: 1Review/editorial: 16Duplicate: 4Unavailable: 2Full text review: 251CEA 18 observational studies5 trials (16 publications)17
Robotic-assisted Surgery in Partial Nephrectomy and CystectomyEvidence Synthesis ProgramKEY QUESTION 1A – CYSTECTOMY: What is the clinical effectivenessof robotic-assisted surgery compared to open surgery orconventional laparoscopic surgery for cystectomy?We identified 16 publications that met the inclusion criteria.9-24 Five studies were randomizedtrials9-14; of note, 2 publications were from the same study, b
As of 2017, over 750,000 robotic procedures are performed each year in the United States including over 125,000 urologic robotic procedures. Despite the rapid adoption of the approach, there is a growing body of literature questioning the utility of robotic surgery compared
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