Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.
As technology continues to evolve, robotic-assisted surgery has the potential to become a widely used attractive alternative to standard laparoscopic donor nephrectomy.
Our study shows that there is considerable public interest in NOTES surgery and women would be receptive to this new surgical technique. Our study highlights a strong need for early reporting of outcomes data to enlighten ourselves, and our patients, about this exciting new technology.
BackgroundBoth long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler.MethodsPatients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months.Results66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60–83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects.ConclusionsThe initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.
The current study shows that RATE, with its decreased blood loss, minimal cardiopulmonary complications, and no hospital mortality, represents a safe and effective alternative for the treatment of esophageal adenocarcinoma.
No lower mortality risk subgroup could be identified in this nationwide collective. This analysis emphasizes that perioperative mortality after esophagectomy for cancer is lower in high-volume hospitals.
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