RESUMO
BACKGROUND: Laparoscopy has enjoyed improvements over the last three decades primarily in achieving high definition, but the 70° field of view (FOV) remains unchanged. Complications related to events that take place out of the FOV continue to be reported. Additional problems leading to poor visualization are fogging and smoke accumulation. A novel laparoscopic system (SurroundScope, 270Surgical) was developed and dramatically expands the FOV from the 70° to 270° by adding side cameras at the distal tip of the laparoscope, while LED illumination eliminates fogging and improves smoke effects. This study describes the initial clinical experience with SurroundScope and its potential advantages over traditional laparoscopy. METHODS: SurroundScope was studied at Bnai Zion Medical Center in Israel and the Minnesota Institute for Minimally Invasive Surgery in America. 27 laparoscopic surgeries were performed, and at the end of each procedure, evaluations were completed by all surgeons and camera holders. RESULTS: All 27 cases were completed successfully without adverse events. No injuries occurred as a result of surgical tool manipulation outside of the central frame while 133 potentially adverse events were identified on side frames. There was no fogging across the 27 cases. The impact of smoke was negligible in all cases, as laparoscope removal or venting was never necessary. Surgeon respondents indicated that tools could be followed from the port to the site of surgery without camera manipulation. Most surgeons strongly agreed that the potential to identify bleeding was improved. Camera holders strongly agreed that the ergonomics were improved and that they moved the camera less than with a standard laparoscope. CONCLUSIONS: Initial results demonstrate numerous advantages for SurroundScope as compared to traditional laparoscopy. The important benefits of expanded FOV, complete lack of fogging, and negligible smoke may improve patient safety, reduce adverse events and the duration of surgery. Further investigation to quantify these benefits is recommended.
Assuntos
Laparoscopia , Cirurgiões , Ergonomia , Humanos , Laparoscópios , Laparoscopia/métodos , Procedimentos Cirúrgicos Minimamente InvasivosRESUMO
OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. RESULTS: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.
Assuntos
Deglutição/fisiologia , Esfíncter Esofágico Inferior/cirurgia , Refluxo Gastroesofágico/cirurgia , Imãs , Adulto , Idoso , Esfíncter Esofágico Inferior/fisiopatologia , Monitoramento do pH Esofágico , Feminino , Seguimentos , Refluxo Gastroesofágico/metabolismo , Refluxo Gastroesofágico/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
For decades, it has been axiomatic that rural health care systems are crucial factors not only in the health of the populations that they serve but also in the viability of America's rural communities. Medical care, as it is delivered in rural America, is becoming increasingly problematic as national health care delivery models evolve. Increasing reimbursement pressures and changing practitioner lifestyle expectations have had negative effects on rural communities and resulted in rural hospital closings and a declining level of surgical care available. These two factors are interrelated, given the importance of surgical services to the revenue stream of any hospital.