Robotic Magnetic Surgery: Results From the First Prospective Clinical Trial.
| Autor: | Romero-Velez G; From the Cleveland Clinic, Cleveland, OH., Robles I; Hospital Fach and Clinica Indisa, Santiago, Chile., Jiménez J; Hospital Luis Tisne, Santiago, Chile., Cabrera C; Hospital Fach and Universidad de Valparaiso, Santiago, Chile., Luengas R; Clinica Red Salud, Santiago, Chile., Portenier D; Duke University, Durham, NC., Kroh M; From the Cleveland Clinic, Cleveland, OH. |
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| Jazyk: | angličtina |
| Zdroj: | Annals of surgery open : perspectives of surgical history, education, and clinical approaches [Ann Surg Open] 2022 Nov 09; Vol. 3 (4), pp. e225. Date of Electronic Publication: 2022 Nov 09 (Print Publication: 2022). |
| DOI: | 10.1097/AS9.0000000000000225 |
| Abstrakt: | To evaluate a novel Magnetic Robotic Platform during reduced-port laparoscopic surgery in a prospective, multicenter clinical trial. Background: Magnetic surgery has been developed to increase the benefits of minimally invasive surgery, with prior studies demonstrating its clinical benefits. Robotic-assisted surgery increases the surgeon's control over the instruments, offering less dependency on an assistant. The synergism of both techniques may escalate these individual benefits. Methods: A prospective, multicenter, single-arm, open-label study was performed to assess the safety and performance of a robotic magnetic surgical system (Levita Robotic Platform). The investigational device was used during reduced-port laparoscopic cholecystectomy and laparoscopic bariatric surgery. The primary endpoints evaluated were safety and feasibility. Patients were followed for 30 days post-procedure. Results: Between May 2021 and December 2021, 30 patients undergoing laparoscopic surgery were recruited. There were 22 females and 8 males with a mean age of 39 years (22-69 years) and median body mass index of 33 kg/m 2 (21.6-50.4 kg/m 2 ). Procedures included 15 gastric sleeves, 14 cholecystectomies, and 1 Roux en-Y gastric bypass. The procedures were successfully performed by utilizing the robotic magnetic surgical system and a reduced-port technique in all 30 patients. No device-related serious adverse events were reported. The device provided adequate visualization and retraction in all cases. Conclusions: This clinical trial shows for the first time that this novel Magnetic Robotic Platform is safe and feasible in reduced-port laparoscopic cholecystectomy and laparoscopic bariatric surgery. This robotic platform brings the benefits of magnetic surgery in terms of reduction of incisions plus increasing the control for the surgeon. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.) |
| Databáze: | MEDLINE |
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