Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices. METHODS: Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting. RESULTS: Searches identified 587 abstracts; 39 full-text papers were included (1 RCT 5 cohort, 3 case-control, 25 case series, 5 case reports). Twenty-one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty-six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year. CONCLUSION: Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness.

ANTECEDENTES: El aumento de esfínter con un dispositivo magnético (magnetic sphincter augmentation, MSA) se ha descrito como una alternativa innovadora a la cirugía antirreflujo para pacientes con enfermedad por reflujo gastroesofágico. Aunque este procedimiento se utiliza en la práctica, se sabe poco acerca de cómo ha sido evaluado. Este estudio se propuso resumir sistemáticamente y evaluar los trabajos sobre MSA y su introducción en la práctica clínica, en el contexto de las guías (como IDEAL) para la evaluación de dispositivos quirúrgicos innovadores. MÉTODOS: Se identificaron todos los estudios publicados que describían la colocación de MSA efectuando búsquedas sistemáticas. Los datos recogidos incluían la selección de los pacientes, disposiciones de gobernanza, experiencia del cirujano, descripción técnica, y descripción de resultados. RESULTADOS: Las búsquedas identificaron 587 resúmenes, incluyéndose 39 artículos completos (5 estudios de cohortes, 3 estudios de casos y controles, 26 series de casos, 5 casos clínicos). En 21 estudios se siguieron los criterios de elegibilidad de la FDA para la colocación de MSA. En 26 estudios se confirmaba que se había obtenido la aprobación ética. Dos estudios describieron que los cirujanos participantes habían recibido formación en MSA; 18 proporcionaron información sobre cómo se realizó la colocación de MSA, aunque las técnicas variaron entre los estudios. El seguimiento oscilaba entre 4 semanas y 5 años; en 14 estudios fue inferior a un año. CONCLUSIÓN: La mayoría de los estudios sobre MSA fueron casos aislados y series de casos, sin un incremento apreciable en la calidad de la evidencia sobre MSA. La información sobre la selección de los pacientes, gobernanza, experiencia, técnicas, y resultados estaba ausente o variaba entre los estudios, haciendo difíciles las comparaciones. En la actualidad, MSA se utiliza a pesar de la falta de evidencia robusta sobre su efectividad.

Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.

BACKGROUND: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE). METHODS: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery. RESULTS: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group. CONCLUSIONS: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.

Integration of clinical and patient-reported outcomes in surgical oncology.

BACKGROUND: Patient-reported outcomes (PROs) provide information about the patient perspective and experience of undergoing surgery for cancer, but evidence suggests that they are not used widely to influence practice. This review considers key challenges and opportunities for using PROs effectively in gastrointestinal surgical oncology, drawing on principles learnt from surgical oncology in general. METHODS: Systematic reviews of randomized controlled trials (RCTs) in surgical oncology reporting PROs as primary or secondary outcomes, and studies examining methods to communicate PRO information, were identified. Common themes are summarized and the future of PRO studies considered. RESULTS: Reviews highlighted the need for improved design, conduct and reporting of PROs in RCTs in surgical oncology. Main issues related to the multiplicity of PRO measures hindering data synthesis and clinical understanding, problems with missing data risking bias, and limited integration of clinical and PRO data undermining the role of PRO data in practice. Reviews indicated that patients want PRO data to meet information needs and early work shows that graphically displayed PROs are understood by patients. CONCLUSION: PROs have a role in the evaluation of surgical oncology, but increased consensus and collaboration between surgeons and methodologists is needed to improve the design, conduct and reporting of PROs with clinical outcomes in trials. Possible solutions include investing more effort and systematic thought into the PRO rationale in RCTs, the development and use of 'core outcome sets' with PROs, and implementation of the extension to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting PROs in RCTs.

Quality of life during potentially curative treatment for locally advanced oesophageal cancer.

BACKGROUND: Combination chemoradiotherapy with or without surgery are internationally applied alternative strategies for potential cure of oesophageal cancer. This study compared health-related quality of life (HRQL) between patients selected for chemoradiation and those who had combination treatment including oesophagectomy. METHODS: Patients with stage II or III oesophageal cancer completed HRQL assessments at baseline, at the worst expected HRQL time point and at expected recovery. HRQL was compared between groups using linear regression, adjusting for age, sex, performance status, tumour stage and type, and baseline HRQL. RESULTS: Some 132 patients began treatment, of whom 51 had chemoradiotherapy and 81 combination treatment including surgery. Patients selected for chemoradiotherapy were older, more likely to have squamous cell cancer and reported poorer HRQL than those selected for surgery. At the worst expected time point after treatment, both groups reported multiple symptoms and poor function, but surgery was associated with a greater reduction in HRQL from baseline than chemoradiotherapy. Recovery of HRQL was achieved within 6 months after chemoradiotherapy, but complete recovery had not occurred 6 months after surgery and there was persistent significant deterioration in some aspects. CONCLUSION: The negative treatment-related impact of chemoradiation on short-term HRQL is less than that experienced with combination treatment including surgery. Patients preferring early recovery should consider definitive chemoradiation.