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首页> 外文期刊>Surgical Endoscopy >Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication
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Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication

机译：磁性括约肌增强和腹腔镜技术的三年临床经验

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Background Magnetic sphincter augmentation (MSA) is a surgical intervention for gastroesophageal reflux disease (GERD) which has been evaluated in numerous studies and has shown beneficial effects. Long-term effectiveness data for MSA as well as laparoscopic fundoplication (LF) in patients with GERD are needed. Objective The objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD. Methods This prospective, multi-center, observational registry study evaluated MSA and LF in clinical practice over 3 years (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, medication use, satisfaction and complications. Post-surgical evaluations were collected at yearly intervals. Results Between December 2009 and December 2014, 631 patients (465 MSA and 166 LF) were enrolled in the registry. Both MSA and LF resulted in improvements in total GERD-HRQL score (mean reduction in GERD-HRQL from baseline to 3 years post-surgery: MSA 22.0 to 4.6 and LF 23.6 to 4.9) and in satisfaction (GERD-HRQL satisfaction increase from baseline to 3 years: MSA 4.6% to 78.2% and LF 3.7% to 76.5%). Most patients were able to belch as needed with both therapies (MSA 97.6% and LF 91.7% at 3 years). MSA allowed a higher percentage of patients the ability to vomit as needed (MSA 91.2% and LF 68.0% at 3 years). PPI usage declined from baseline to 3 years for both groups after surgery (MSA 97.8% to 24.2% and LF 95.8% to 19.5%). The mean procedure time was shorter for MSA than for LF. Intraoperative and procedure-related complication rates (<= 2%) were low for both therapies. Conclusions This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of MSA and LF. Despite the more severe nature of GERD in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint.
机译：背景磁括约肌增强术（MSA）是治疗胃食管反流病（GERD）的一种外科治疗方法，已在许多研究中得到评估，并显示出有益的效果。需要对胃食管反流患者进行MSA和腹腔镜胃底折叠术（LF）的长期疗效数据。目的本研究的目的是评估GERD患者MSA和LF的3年预后。方法这项前瞻性、多中心、观察性注册研究评估了3年来临床实践中的MSA和LF（ClinicalTrials.gov标识符：NCT01624506）。数据收集包括基线特征、反流症状、药物使用、满意度和并发症。术后评估每年收集一次。结果在2009年12月至2014年12月期间，631名患者（465名MSA患者和166名LF患者）被纳入登记册。MSA和LF均改善了GERD-HRQL总分（从基线检查到术后3年，GERD-HRQL平均下降：MSA 22.0至4.6，LF 23.6至4.9）和满意度（GERD-HRQL满意度从基线检查到3年，MSA 4.6%至78.2%，LF 3.7%至76.5%）。大多数患者都能根据需要使用这两种疗法打嗝（3年时MSA为97.6%，LF为91.7%）。MSA允许更高比例的患者根据需要呕吐（3年时MSA为91.2%，LF为68.0%）。两组患者术后PPI使用率均从基线水平下降至3年（MSA 97.8%至24.2%，LF 95.8%至19.5%）。MSA的平均手术时间比LF短。两种疗法的术中和手术相关并发症发生率均较低（<=2%）。结论这项为期3年的前瞻性观察登记研究为MSA和LF的有效性提供了越来越多的证据。尽管LF组GERD的性质更为严重，但从有效性和安全性的角度来看，MSA和LF的临床结果是有利的。

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