Abstract
This study evaluated the safety and efficacy of the newly developed Revo-i (Meerecompany, Yongin, Republic of Korea) robotic surgical system during robot-assisted cholecystectomy. This prospective, phase I clinical study involved 15 patients with gallbladder-related disease. The primary outcome evaluated was the intraoperative safety of the Revo-i; the secondary outcomes measured were the 30-day postoperative complications and patient satisfaction with the Revo-i’s performance. Between August 17 and December 23, 2016, we performed 15 robot-assisted cholecystectomies. The operations were successfully completed, without any conversions to open or laparoscopic approaches. The mean patient age (53.07 years), mean operative time (115.3 ± 17.31 min [± standard deviation]), docking time (10.6 ± 3.16 min), console time (49.7 ± 15.41 min), actual dissection time (33.1 ± 10.53 min), and estimated blood loss (3.33 ± 6.17 mL) were determined. There were no intra- or postoperative complications, including gallbladder perforations. The mean hospital stay was 2.0 ± 1.00 days. Most patients reported satisfaction with the Revo-i’s performance. Performing robot-assisted cholecystectomies using the Revo-i is feasible and safe. This report describes the first clinical study of the Revo-i robotic surgical system in human patients.
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Acknowledgements
This work was supported by a National Research Foundation of Korea grant funded by the Korea Government (NRF-2015R1A2A2A04003460). The funding agency had no role in the data collection, study design, or writing of the manuscript. Dr. W.J. Lee serves as a consultant for Meerecompany (Yongin, Republic of Korea). The other authors have no conflicts of interest or financial ties to disclose.
Funding
This work was supported by a National Research Foundation of Korea Grant, funded by the Korea Government (NRF-2015R1A2A2A04003460). The funding body did not have a role in the data collection, study design, or writing of the manuscript.
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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by JHL, SHC and CMK. WJL provided advice about robotic systems and the setting up of a clinical trial. The first draft of the manuscript was written by JHL and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This work was supported by a National Research Foundation of Korea Grant funded by the Korea Government (NRF-2015R1A2A2A04003460). The funding agency had no role in the data collection, study design, or writing of the manuscript. Dr. W. J. Lee serves as a consultant for Meerecompany (Yongin, Republic of Korea). He was not involved in the surgeries, data collection, or analyses. He provided advice about robotic systems and the setting up of a clinical trial. None of the other authors have conflicts of interest or financial ties to disclose.
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Severance Hospital Institutional Review Board approved the current human study protocol (No. 1–2016-0019).
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Informed consent was obtained from all individual participants included in the study.
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Lim, J.H., Lee, W.J., Choi, S.H. et al. Cholecystectomy using the Revo-i robotic surgical system from Korea: the first clinical study. Updates Surg 73, 1029–1035 (2021). https://doi.org/10.1007/s13304-020-00877-5
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DOI: https://doi.org/10.1007/s13304-020-00877-5