磁括约肌增强和腹腔镜胃底折叠术的三年临床经验。
Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication.
机构信息
Division of General and Foregut Surgery, Department of Biomedical Sciences for Health, University of Milano, IRCCS Policlinico San Donato, Milano, Italy.
Department of Surgery, Schön Klinik Nürnberg Fürth, 90763, Fürth, Germany.
出版信息
Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.
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.
背景
磁括约肌增强术（MSA）是一种治疗胃食管反流病（GERD）的手术干预措施，已在多项研究中进行了评估，并显示出有益的效果。需要长期评估 MSA 和腹腔镜胃底折叠术（LF）治疗 GERD 的有效性数据。
目的
本研究旨在评估 MSA 和 LF 治疗 GERD 患者的 3 年疗效。
方法
这是一项前瞻性、多中心、观察性注册研究，在 3 年内（ClinicalTrials.gov 标识符：NCT01624506）评估了 MSA 和 LF 在临床实践中的应用。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。术后评估每年进行一次。
结果
2009 年 12 月至 2014 年 12 月期间，共纳入 631 例患者（MSA 465 例，LF 166 例）。MSA 和 LF 均能改善总 GERD-HRQL 评分（从基线到术后 3 年 GERD-HRQL 的平均降低值：MSA 22.0 至 4.6，LF 23.6 至 4.9）和满意度（从基线到术后 3 年 GERD-HRQL 满意度的增加值：MSA 4.6%至 78.2%，LF 3.7%至 76.5%）。两种治疗方法均能使大多数患者按需嗳气（MSA 3 年时 97.6%，LF 91.7%）。MSA 使更多的患者能够按需呕吐（MSA 3 年时 91.2%，LF 68.0%）。两组患者术后 PPI 使用量均从基线下降至 3 年（MSA 97.8%至 24.2%，LF 95.8%至 19.5%）。MSA 的手术时间短于 LF。两种治疗方法的术中及手术相关并发症发生率（≤2%）均较低。
结论
本前瞻性观察性注册研究为 MSA 和 LF 的有效性提供了更多证据。尽管 LF 组的 GERD 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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