Esophageal sphincter device for gastroesophageal reflux disease

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.

Therapy interventions for children with neurodisability : a qualitative scoping study of current practice and perceived research needs.

Background: Therapy interventions emerged four times in the top 10 research priorities in a James Lind Alliance research prioritisation exercise for children with neurodisabilities (Morris C, Simkiss D, Busk M, Morris M, Allard A, Denness J, et al. Setting research priorities to improve the health of children and young people with neurodisability: a British Academy of Childhood Disability-James Lind Alliance Research Priority Setting Partnership. BMJ Open 2015;5:e006233). The National Institute for Health Research (NIHR) commissioned this study as part of an information-gathering exercise in response to this. Objectives: The objectives were to (1) describe the current practice, approaches and schools of thought in relation to physiotherapy, occupational therapy and speech and language therapy for children with neurodisability; (2) explore clinical decision-making; (3) investigate views on outcomes and their measurement, particularly participation as an outcome, that is, the child’s ability to have the opportunity to be involved in life situations and activities (e.g. communication, mobility, interpersonal interactions, self-care, learning and applying knowledge); (4) seek views on the aspects of therapy interventions that have an impact on outcomes; and (5) elicit stakeholder views on research needs and priorities. Design, setting and participants: More than 70 professionals (therapists, service leads, paediatricians and education staff) and 25 parents participated in a qualitative interview (either individually or as part of a focus group). Results: Professional thinking and models of service delivery are in a state of flux and development. There is a move towards goals-focused, family-centred approaches. Work tends to be highly individualised, with few protocols. Parents are certain of the value of therapies, although they may experience difficulties with provision and may seek (additional) private provision. Therapy interventions are conceived as three components: the therapist, the procedures/equipment, etc., and the wider therapeutic environment. They are believed to be highly complex and poorly understood. Although participation is widely endorsed as a core intervention objective of therapy interventions, its suitability, or appropriateness, as an outcome measure was questioned. Other child and/or parent outcomes were identified as more or equally important. Notions of intermediate outcomes – in terms of body structure/function, and the achievement of activities – were regarded as important and not counter to participation-focused approaches. Among therapists, research on intervention effectiveness was (cautiously) welcomed. A number of methodological challenges were identified. A portfolio of study designs – quantitative and qualitative, experimental and observational – was called for, and which included economic evaluation and clear pathways to impact. Limitations: The study was not successful in recruiting children and young people. Further work is required to elucidate the views of this key stakeholder group. Conclusions: Therapy interventions are poorly understood. There was strong support, tempered a little by concerns among some about the feasibility of demonstrating impact, for investment in research

Laparoscopic Transhiatal Esophagectomy for Invasive Esophageal Adenocarcinoma.

BACKGROUND: Esophagectomy is a fundamental step to achieve long-term disease-free survival in esophageal cancer. While various approaches have been described, there is no consensus on the single best technique to optimize operative and oncologic outcomes. We aim to report the modern experience with laparoscopic transhiatal esophagectomy (LTHE) for invasive adenocarcinoma. METHODS: We reviewed all patients who underwent LTHE with extended lymph node dissection for distal esophageal adenocarcinoma (EAC) at our institution between 2007 and 2016. Pre-operative characteristics, operative details, postoperative complications, and long-term outcomes were tracked by review of the electronic medical record and patient surveys. Survival rates were calculated with Kaplan-Meier curves. RESULTS: Eighty-two EAC patients underwent LTHE during the study period (84% male, mean age 65, mean BMI 27.8, large). Most patients were clinical stage III (42.7%) and 68.3% had received neoadjuvant chemoradiation (nCRT). Laparoscopy was successful in 93.9%, with five cases requiring conversion to open (6.1%). The median lymph node harvest was 19. Overall complication rate (major and minor) was 45.5% and ninety-day mortality was 4%. Overall 5-year survival was 52% (77% for stage 1, 57% for stage 2, 37% for stage 3). CONCLUSIONS: Laparoscopic transhiatal esophagectomy has an important role in current esophageal cancer treatment and can be performed with curative intent in patients with distal esophageal tumors. In addition to the well-known advantages of laparoscopy, the increased mediastinal visibility and a modern focus on oncologic principles seem to have a positive impact on cancer survival compared to the open transhiatal approach