Robotic Magnetic Surgery: Results From the First Prospective Clinical Trial.

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/m2 (21.6-50.4 kg/m2). 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.

First in-human experience with a novel robotic platform and Magnetic Surgery System.

BACKGROUND: Magnetic technologies have been introduced to reduce invasiveness of surgical procedures. This study was aimed to analyse the performance of a novel combined magnetic-robotic controller as an enhanced accessory to the Magnetic Surgical System in laparoscopic cholecystectomy (LC). METHODS: This was a prospective study of 10 consecutive patients undergoing LC with this novel surgical system. RESULTS: Ten patients were included, nine were female. The mean age was 30.3 ± 9 years. All patients had chronic cholecystitis. Procedures were completed successfully. The median operative time was 50 ± 11 min. The system performed effectively in all cases with no need of additional interventions. There were no device-related complications or side effects. All patients were discharged the same day. Recovery was uneventful during follow-up. CONCLUSIONS: This study demonstrates the first in-human successful performance of surgeries utilizing a novel combination of magnetic and robotic technologies in one integrated system.

First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction.

BACKGROUND: Exposure of the surgical field is an essential component of minimally invasive surgery. Liver retraction is an important element of bariatric procedures because visualization of the stomach and gastroesophageal junction is key. The magnetic surgical system provides a well-tolerated and effective option for adjustable liver retraction without the use of a dedicated port. OBJECTIVE: The purpose of this study was to evaluate the safety profile and effectiveness of the magnetic surgical system in patients undergoing bariatric procedures. SETTING: Two investigational sites in Chile. METHODS: A prospective, single-arm study (ClinicalTrials.govNCT03508674) with adherence to Good Clinical Practices and ISO 14155:2011(E) was undertaken to evaluate the safety profile and effectiveness of the magnetic surgical system in patients undergoing bariatric surgery. Patient follow-up occurred at 7 and 30 days postprocedure. RESULTS: A total of 50 patients who met the inclusion criteria had a body mass index ranging from 28.4 to 58.2 kg/m2. All procedures were completed without complications or conversions. The average overall procedure time was 61 minutes, and the amount of coupling time between the magnetic controller and the detachable grasper was 37 minutes. In all cases the device was able to adequately retract the liver to achieve an effective exposure of the target tissue and perform the bariatric procedure. A total of 24 adverse effects were reported throughout the course of the study. All device-related adverse effects were mild in severity and resolved with no clinical sequelae. CONCLUSION: The magnetic surgical system is a well-tolerated and effective option for liver retraction in minimally invasive and bariatric surgery in patients with a varying range of body mass indexes.

[Prolonged prone position ventilation for severe respiratory distress syndrome post-pneumonectomy. Report of one case]. / Ventilación en posición prono prolongada como alternativa en el tratamiento del síndrome de distrés respiratorio agudo grave posneumonectomía. Caso clínico.

Management of patients with severe respiratory failure is mainly supportive, and protective mechanical ventilation is the pivotal treatment. When conventional therapy is insufficient to improve oxygenation without deleterious effects, other strategies should be considered. We report a 53 year-old male who presented a severe respiratory failure refractory to conventional management after pneumonectomy. Prone position ventilation was used for 36 hours. Respiratory variables improved and he did not show hemodynamic instability. He was returned to the supine position without worsening of oxygenation parameters. Extended prone position ventilation could be considered in patients presenting with unresponsive severe respiratory failure after pulmonary resection.

Ventilación en posición prono prolongada como alternativa en el tratamiento del síndrome de distrés respiratorio agudo grave posneumonectomía: Caso clínico / Prolonged prone position ventilation for severe respiratory distress syndrome post-pneumonectomy: Report of one case

Management of patients with severe respiratory failure is mainly supportive, and protective mechanical ventilation is the pivotal treatment. When conventional therapy is insufficient to improve oxygenation without deleterious effects, other strategies should be considered. We report a 53 year-old male who presented a severe respiratory failure refractory to conventional management after pneumonectomy. Prone position ventilation was used for 36 hours. Respiratory variables improved and he did not show hemodynamic instability. He was returned to the supine position without worsening of oxygenation parameters. Extended prone position ventilation could be considered in patients presenting with unresponsive severe respiratory failure after pulmonary resection.

[Comparison of the endoscopic aspect of the cardia, manometry and 24 hours pH measurement in patients with chronic gastroesophageal reflux]. / Comparación entre el aspecto endoscópico del cardias, hallazgos manométricos y pHmetría de 24 horas en pacientes con síntomas de reflujo gastroesofágico crónico.

BACKGROUND: The endoscopic view of the gastric cardia could be related with the manometric competence of the lower esophageal sphincter (LES) and with pathological gastroesophageal reflux. AIM: To compare the endoscopic aspect of the cardia with the results from esophageal manometry and 24 h esophageal pH monitoring. MATERIALS AND METHODS: The cardia of a group of 150 patients (aged 19 to 72 years, 89 women) with gastroesophageal reflux symptoms was classified as normal or open, during upper gastrointestinal endoscopy. All subjects were subjected to a manometric study to measure LES pressure and determine LES incompetence and to a 24 h esophageal pH measurement. RESULTS: LES pressure was 14.7+/-6.2 and 8.7+/-4.2 mmHg in patients with normal and open cardia, respectvively (p <0.001). Likewise, 43 and 79% of patients with normal and open cardia had an incompetent LES, respectively (p <0.001). Pathological acid reflux was present in 43 and 71% of patients with normal or open cardia, respectively (p <0.001). CONCLUSIONS: The endoscopic appearance of the cardia can identify patients with pathological gastroesophageal reflux.