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      Safe implementation of robotic gastrectomy for gastric cancer under the requirements for universal health insurance coverage: a retrospective cohort study using a nationwide registry database in Japan

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          Abstract

          Background

          Robotic gastrectomy (RG) has increased since being covered by universal health insurance in 2018. However, to ensure patient safety the operating surgeon and facility must meet specific requirements. We aimed to determine whether RG has been safely implemented under the requirements for universal health insurance in Japan.

          Methods

          Data of consecutive patients with primary gastric cancer who underwent minimally invasive total or distal gastrectomy—performed by a surgeon certified by the Japan Society for Endoscopic Surgery (JSES) endoscopic surgical skill qualification system (ESSQS) between October 2018 and December 2019—were extracted from the gastrointestinal surgery section of the National Clinical Database (NCD). The primary outcome was morbidity over Clavien–Dindo classification grade IIIa. Patient demographics and hospital volume were matched between RG and laparoscopic gastrectomy (LG) using propensity score-matched analysis (PSM), and the short-term outcomes of RG and LG were compared.

          Results

          After PSM, 2671 patients who underwent RG and 2671 who underwent LG were retrieved (from a total of 9881), and the standardized difference of all the confounding factors reduced to 0.07 or less. Morbidity rates did not differ between the RG and LG patients (RG, 4.9% vs. LG, 3.9%; p = 0.084). No difference was observed in 30-day mortality (RG, 0.2% vs. LG, 0.1%; p = 0.754). The reoperation rate was greater following RG (RG, 2.2% vs. LG, 1.2%; p = 0.004); however, the duration of postoperative hospitalization was shorter (RG, 10 [8–13] days vs. LG, 11 [9–14] days; p < 0.001).

          Conclusions

          Insurance-covered RG has been safely implemented nationwide.

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          Most cited references35

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          Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

          This article provides an update on the global cancer burden using the GLOBOCAN 2020 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer. Worldwide, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. Overall incidence was from 2-fold to 3-fold higher in transitioned versus transitioning countries for both sexes, whereas mortality varied <2-fold for men and little for women. Death rates for female breast and cervical cancers, however, were considerably higher in transitioning versus transitioned countries (15.0 vs 12.8 per 100,000 and 12.4 vs 5.2 per 100,000, respectively). The global cancer burden is expected to be 28.4 million cases in 2040, a 47% rise from 2020, with a larger increase in transitioning (64% to 95%) versus transitioned (32% to 56%) countries due to demographic changes, although this may be further exacerbated by increasing risk factors associated with globalization and a growing economy. Efforts to build a sustainable infrastructure for the dissemination of cancer prevention measures and provision of cancer care in transitioning countries is critical for global cancer control.
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            Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

            Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
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              The Clavien-Dindo classification of surgical complications: five-year experience.

              The lack of consensus on how to define and grade adverse postoperative events has greatly hampered the evaluation of surgical procedures. A new classification of complications, initiated in 1992, was updated 5 years ago. It is based on the type of therapy needed to correct the complication. The principle of the classification was to be simple, reproducible, flexible, and applicable irrespective of the cultural background. The aim of the current study was to critically evaluate this classification from the perspective of its use in the literature, by assessing interobserver variability in grading complex complication scenarios and to correlate the classification grades with patients', nurses', and doctors' perception. Reports from the literature using the classification system were systematically analyzed. Next, 11 scenarios illustrating difficult cases were prepared to develop a consensus on how to rank the various complications. Third, 7 centers from different continents, having routinely used the classification, independently assessed the 11 scenarios. An agreement analysis was performed to test the accuracy and reliability of the classification. Finally, the perception of the severity was tested in patients, nurses, and physicians by presenting 30 scenarios, each illustrating a specific grade of complication. We noted a dramatic increase in the use of the classification in many fields of surgery. About half of the studies used the contracted form, whereas the rest used the full range of grading. Two-thirds of the publications avoided subjective terms such as minor or major complications. The study of 11 difficult cases among various centers revealed a high degree of agreement in identifying and ranking complications (89% agreement), and enabled a better definition of unclear situations. Each grade of complications significantly correlated with the perception by patients, nurses, and physicians (P < 0.05, Kruskal-Wallis test). This 5-year evaluation provides strong evidence that the classification is valid and applicable worldwide in many fields of surgery. No modification in the general principle of classification is warranted in view of the use in ongoing publications and trials. Subjective, inaccurate, or confusing terms such as "minor or major" should be removed from the surgical literature.
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                Author and article information

                Contributors
                ko-suda@nifty.com
                Journal
                Gastric Cancer
                Gastric Cancer
                Gastric Cancer
                Springer Singapore (Singapore )
                1436-3291
                1436-3305
                12 October 2021
                : 1-12
                Affiliations
                [1 ]GRID grid.256115.4, ISNI 0000 0004 1761 798X, Department of Surgery, , Fujita Health University, ; 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192 Japan
                [2 ]GRID grid.256115.4, ISNI 0000 0004 1761 798X, Collaborative Laboratory for Research and Development in Advanced Surgical Intelligence, , Fujita Health University, ; Toyoake, Japan
                [3 ]GRID grid.26999.3d, ISNI 0000 0001 2151 536X, Department of Healthcare Quality Assessment, Graduate School of Medicine, , The University of Tokyo, ; Tokyo, Japan
                [4 ]GRID grid.258799.8, ISNI 0000 0004 0372 2033, Department of Surgery, Graduate School of Medicine, , Kyoto University, ; Kyoto, Japan
                [5 ]GRID grid.412339.e, ISNI 0000 0001 1172 4459, Department of Surgery, , Saga University Faculty of Medicine, ; Saga, Japan
                [6 ]GRID grid.415797.9, ISNI 0000 0004 1774 9501, Division of Gastric Surgery, , Shizuoka Cancer Center, ; Shizuoka, Japan
                [7 ]GRID grid.256115.4, ISNI 0000 0004 1761 798X, Collaborative Laboratory for Research and Development in Advanced Surgical Technology, , Fujita Health University, ; Toyoake, Japan
                [8 ]GRID grid.508245.e, Database Committee, , The Japanese Society of Gastroenterological Surgery, ; Tokyo, Japan
                [9 ]Academic Committee, The Japan Society for Endoscopic Surgery, Tokyo, Japan
                [10 ]GRID grid.508245.e, The Japanese Society of Gastroenterological Surgery, ; Tokyo, Japan
                [11 ]GRID grid.256115.4, ISNI 0000 0004 1761 798X, Department of Advanced Robotic and Endoscopic Surgery, , Fujita Health University, ; Toyoake, Japan
                Author information
                http://orcid.org/0000-0002-0423-1565
                Article
                1257
                10.1007/s10120-021-01257-7
                8505217
                34637042
                dcf70b5f-67c7-480a-a8d3-1114b69f4f54
                © The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2021

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                : 11 September 2021
                : 1 October 2021
                Categories
                Original Article

                Oncology & Radiotherapy
                stomach neoplasms,gastrectomy,robotic surgical procedure,minimally invasive surgical procedures,postoperative complications

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