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      Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes : A Randomized Clinical Trial

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          Key Points

          Question

          Does the use of 3-dimensional, virtual reality models for planning robotic-assisted partial nephrectomy improve surgical outcomes?

          Findings

          In this single-blind randomized clinical trial involving 92 patients, the use of 3-dimensional virtual reality models reduced the operative time, estimated blood loss, clamp time, and length of hospital stay.

          Meaning

          This randomized clinical trial demonstrates key outcomes improvements when using 3-dimensional, virtual reality models to plan robotic-assisted partial nephrectomy.

          Abstract

          This single-blind randomized clinical trial examines whether 3-dimensional (3-D) virtual reality models used to plan robotic-assisted partial nephrectomy can reduce the operative time, estimated blood loss, clamp time, and length of hospital stay.

          Abstract

          Importance

          Planning complex operations such as robotic-assisted partial nephrectomy requires surgeons to review 2-dimensional computed tomography or magnetic resonance images to understand 3-dimensional (3-D), patient-specific anatomy.

          Objective

          To determine surgical outcomes for robotic-assisted partial nephrectomy when surgeons reviewed 3-D virtual reality (VR) models during operative planning.

          Design, Setting, and Participants

          A single-blind randomized clinical trial was performed. Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals were prospectively enrolled and randomized. Enrollment and data collection occurred from October 2017 through December 2018, and data analysis was performed from December 2018 through March 2019.

          Interventions

          Patients were assigned to either a control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model. This model was viewed on the surgeon’s smartphone in regular 3-D format and in VR using a VR headset.

          Main Outcomes and Measures

          The primary outcome measure was operative time. It was hypothesized that the operations performed using the 3-D VR models would have shorter operative time than those performed without the models. Secondary outcomes included clamp time, estimated blood loss, and length of hospital stay.

          Results

          Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed. The analysis included 48 patients randomized to the control group and 44 randomized to the intervention group. When controlling for case complexity and other covariates, patients whose surgical planning involved 3-D VR models showed differences in operative time (odds ratio [OR], 1.00; 95% CI, 0.37-2.70; estimated OR, 2.47), estimated blood loss (OR, 1.98; 95% CI, 1.04-3.78; estimated OR, 4.56), clamp time (OR, 1.60; 95% CI, 0.79-3.23; estimated OR, 11.22), and length of hospital stay (OR, 2.86; 95% CI, 1.59-5.14; estimated OR, 5.43). Estimated ORs were calculated using the parameter estimates from the generalized estimating equation model. Referent group values for each covariate and the corresponding nephrometry score were summed across the covariates and nephrometry score, and the sum was exponentiated to obtain the OR. A mean of the estimated OR weighted by sample size for each nephrometry score strata was then calculated.

          Conclusions and Relevance

          This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay.

          Trial Registration

          ClinicalTrials.gov identifiers (1 registration per site): NCT03334344, NCT03421418, NCT03534206, NCT03542565, NCT03556943, and NCT03666104

          Related collections

          Most cited references31

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          The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth.

          Treatment decisions for renal malignancies depend largely on qualitative data, including a description of tumor anatomy and the experience of the treating surgeon. Currently characterization of renal tumor anatomical elements is descriptive and lacks standardization. Surgical decision making and data set comparisons would be significantly enhanced by a consistent, reproducible system that quantitates the pertinent characteristics of localized renal lesions. We have developed and propose a standardized nephrometry scoring system (R.E.N.A.L. Nephrometry Score) to quantify the anatomical characteristics of renal masses on computerized tomography/magnetic resonance imaging. The nephrometry score is based on 5 critical and reproducible anatomical features of solid renal masses. Of the 5 components 4 are scored on a 1, 2 or 3-point scale with the 5th indicating the anterior or posterior location of the mass relative to the coronal plane of the kidney. We applied the R.E.N.A.L. Nephrometry Score to 50 consecutive masses resected at Fox Chase Cancer Center. The R.E.N.A.L. Nephrometry Score consists of (R)adius (tumor size as maximal diameter), (E)xophytic/endophytic properties of the tumor, (N)earness of tumor deepest portion to the collecting system or sinus, (A)nterior (a)/posterior (p) descriptor and the (L)ocation relative to the polar line. The suffix h (hilar) is assigned to tumors that abut the main renal artery or vein. The nephrometry scoring system accurately classified the complexity of 50 consecutive tumors undergoing excision at our institution. Standardized reporting of renal tumor size, location and depth is essential for decision making and effective comparisons. The R.E.N.A.L. Nephrometry Score is a reproducible standardized classification system that quantitates the salient anatomy of renal masses. This novel approach for the systematic characterization of renal tumors provides a tool for meaningful comparisons of renal masses in clinical practice and in the urological literature.
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            Chronic kidney disease after nephrectomy in patients with renal cortical tumours: a retrospective cohort study.

            Chronic kidney disease is a graded and independent risk factor for substantial comorbidity and death. We aimed to examine new onset of chronic kidney disease in patients with small, renal cortical tumours undergoing radical or partial nephrectomy. We did a retrospective cohort study of 662 patients with a normal concentration of serum creatinine and two healthy kidneys undergoing elective partial or radical nephrectomy for a solitary, renal cortical tumour (
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              • Article: not found

              Partial nephrectomy versus radical nephrectomy in patients with small renal tumors--is there a difference in mortality and cardiovascular outcomes?

              Compared with partial nephrectomy, radical nephrectomy increases the risk of chronic kidney disease, which is a significant risk factor for cardiovascular events and death. Given equivalent oncological efficacy in patients with small renal tumors, radical nephrectomy may result in overtreatment. We analyzed a population based cohort of patients to determine whether radical nephrectomy is associated with an increase in cardiovascular events and mortality compared with partial nephrectomy. Using Surveillance, Epidemiology and End Results cancer registry data linked with Medicare claims we identified 2,991 patients older than 66 years who were treated with radical or partial nephrectomy for renal tumors 4 cm or less between 1995 and 2002. The primary end points of cardiovascular events and overall survival were assessed using Kaplan-Meier survival estimation, Cox proportional hazards regression and negative binomial regression. A total of 2,547 patients (81%) underwent radical nephrectomy and 556 (19%) underwent partial nephrectomy. During a median followup of 4 years 609 patients experienced a cardiovascular event and 892 died. When adjusting for preoperative demographic and comorbid variables, radical nephrectomy was associated with an increased risk of overall mortality (HR 1.38, p <0.01) and a 1.4 times greater number of cardiovascular events after surgery (p <0.05). However, radical nephrectomy was not significantly associated with time to first cardiovascular event (HR 1.21, p = 0.10) or with cardiovascular death (HR 0.95, p = 0.84). Radical nephrectomy, which is currently the most common treatment for small renal tumors, may be associated with significant, adverse treatment effects compared with partial nephrectomy. Partial nephrectomy should be considered in most patients with small renal tumors.
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                Author and article information

                Journal
                JAMA Netw Open
                JAMA Netw Open
                JAMA Network Open
                American Medical Association
                2574-3805
                18 September 2019
                September 2019
                18 September 2019
                : 2
                : 9
                : e1911598
                Affiliations
                [1 ]David Geffen School of Medicine, Department of Urology, University of California, Los Angeles
                [2 ]Department of Urology, Mayo Clinic Florida, Jacksonville
                [3 ]Chapel Hill School of Medicine, Department of Urology, University of North Carolina, Chapel Hill
                [4 ]John Wayne Cancer Institute, Providence St John’s Health Center, Santa Monica, California
                [5 ]Department of Urology, The University of Tennessee Medical Center, Knoxville
                [6 ]Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York
                [7 ]Swedish Urology Group, Seattle, Washington
                Author notes
                Article Information
                Accepted for Publication: July 29, 2019.
                Published: September 18, 2019. doi:10.1001/jamanetworkopen.2019.11598
                Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2019 Shirk JD et al. JAMA Network Open.
                Corresponding Author: Joseph D. Shirk, MD, David Geffen School of Medicine, Department of Urology, University of California, Los Angeles, 300 Stein Plaza, Third Floor, Los Angeles, CA 90095 ( jshirk@ 123456mednet.ucla.edu ).
                Author Contributions: Dr Shirk had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Shirk, Wallen, White.
                Acquisition, analysis, or interpretation of data: All authors.
                Drafting of the manuscript: Shirk.
                Critical revision of the manuscript for important intellectual content: All authors.
                Statistical analysis: Shirk.
                Obtained funding: Shirk.
                Administrative, technical, or material support: Shirk, Thiel, White, Porter.
                Supervision: Shirk, Wallen, Badani.
                Conflict of Interest Disclosures: Dr Shirk reported serving as a consultant for and having a financial relationship with Ceevra, Inc. Dr Thiel reported owning stock in Auris. Dr Porter reported receiving a grant from Ceevra, Inc during the conduct of the study. No other disclosures were reported.
                Funding/Support: Ceevra, Inc provided funding for research support to Swedish Urology Group and provided the models to all sites without charge.
                Role of the Funder/Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The sponsor had the right to review the manuscript but had no authority to change any aspect of it. The sponsor does not have any proprietary interest in the model used in this study.
                Additional Contributions: The entirety of the statistical analysis was performed by statistician Lorna Kwan, MS (Department of Urology, University of California, Los Angeles), who received a stipend for this work.
                Data Sharing Statement: See Supplement 3.
                Article
                zoi190452
                10.1001/jamanetworkopen.2019.11598
                6751754
                31532520
                1897195a-a5e0-4528-bef7-4e791c7ccfd1
                Copyright 2019 Shirk JD et al. JAMA Network Open.

                This is an open access article distributed under the terms of the CC-BY-NC-ND License.

                History
                : 17 June 2019
                : 29 July 2019
                Categories
                Research
                Original Investigation
                Online Only
                Urology

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