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首页> 外文期刊>Surgical Endoscopy >Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX.
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Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX.

机译：使用EsophyX进行抗反流经口无切口胃底折叠术可行性研究的两年结果。

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BACKGROUND: A feasibility study (n = 19) evaluated the safety and initial efficacy of transoral incisionless fundoplication (TIF) for the treatment of gastroesophageal disease (GERD). The results at 1 year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia. This study was designed to evaluate the long-term safety and durability of TIF. METHODS: Fourteen patients (50% female; median age, 34 years) completed the 2-year follow-up assessment tests. Three patients were excluded from the study after 1 year because two of them underwent retreatment and one was lost to follow-up. RESULTS: At 2 years, no adverse events related to TIF were reported. A >or=50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (p < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared with baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced complete cure (29%) or remission (50%) of GERD at 2 years after TIF. CONCLUSION: The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis,
机译：背景：一项可行性研究（n = 19）评估了经口无切口胃底折叠术（TIF）治疗胃食管疾病（GERD）的安全性和初始疗效。 1年（n = 17）时的结果表明，TIF是安全的，并且对减少GERD症状，质子泵抑制剂（PPI）使用，酸暴露和小裂孔疝具有显著作用。这项研究旨在评估TIF的长期安全性和耐用性。方法：14名患者（女性占50％;中位年龄34岁）完成了为期2年的随访评估测试。 1年后有3例患者被排除在研究之外，因为其中2例接受了再治疗，其中1例失去了随访。结果：在2年时，未报告与TIF相关的不良事件。与基线时相比，PPIs的GERD-HRQL分数提高了> == 50％，这一比例持续了64％的患者。 TIF可有效消除93％的患者的胃灼热和71％的患者的每日PPI治疗。与PPIs的基线相比，有更多（p <0.05）的患者能够食用引起反流的食物并维持没有GERD症状的生活方式。胃底折叠术是持久的，并保持其几何尺寸。 TIF可有效消除60％的患者的食管裂孔疝和55％的患者的食管炎。对每位患者的所有结局进行的总体评估表明，在TIF后2年，有79％的患者经历了GERD的完全治愈（29％）或缓解（50％）。结论：2年的结果支持TIF的长期安全性和持久性，并且对消除烧心，食道炎，<2 cm食管裂孔疝和每日依赖PPI的持续效果具有支持作用。

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