TEMPO 5年试用：经口胃底折叠术（TIF 2.0）安全，耐用且具有成本效益。,Surgical Innovation

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TEMPO 5年试用：经口胃底折叠术（TIF 2.0）安全，耐用且具有成本效益。
Surgical Innovation ( IF 1.2 ) Pub Date : 2018-02-07 , DOI: 10.1177/1553350618755214
Karim S Trad _{1,

2} , William E Barnes ₃ , Elizabeth R Prevou ₂ , Gilbert Simoni ₄ , Jennifer A Steffen ₂ , Ahmad B Shughoury _{5,

6} , Mamoon Raza _{7,

8} , Jeffrey A Heise ₉ , Mark A Fox _{10,

11} , Peter G Mavrelis _{5,

6}

Affiliation

背景技术关于经口无切口胃底折叠术（TIF）的治疗持久性仍然存在疑问。在这项研究中，在TIF 2.0后5年评估了临床结局。方法将63例慢性胃食管反流病（GERD）患者（其症状难以接受质子泵抑制剂（PPI）治疗，不存在或≤2 cm食管裂孔疝和异常食管酸暴露）随机分为TIF组或PPI组。经过6个月的评估，PPI组中的所有患者都选择了转用TIF；因此，所有63例患者均接受了带EsophyX2装置的TIF 2.0。主要结果是在5年的随访中消除了日常麻烦的反流和非典型症状。次要结果是症状评分，PPI使用，再次手术和患者健康满意度的改善。还估计了TIF 2.0的成本效益。结果63例患者中，有60例在1年时可用，52例在3年时可用，44例在5年时可用。1年时88％的患者消除了麻烦的反流，3年时90％的患者消除了，5年时86％的患者消除了。1年时82％的患者，3年时88％的患者和5年时80％的患者可以解决麻烦的非典型症状。没有发生严重的不良事件。到5年随访结束时，共进行了3次手术。在5年的随访中，有34％的患者接受每日PPI治疗，而接受筛查的患者为100％。与GERD健康相关的总生活质量得分得到改善，在5年时从22.2降低到6.8（P <.001）。结论在该患者人群中，TIF为2。

"点击查看英文标题和摘要"

The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

BACKGROUND Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001). CONCLUSION In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

更新日期：2019-11-01

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