Trial reportSurgical endoscopy2018
Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease.
Trial report in Surgical endoscopy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Magnetic sphincter augmentation in the management of gastro-esophageal reflux disease: a systematic review and meta-analysis.International journal of surgery (London, England) · 2024Pooled it
- Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease.The British journal of surgery · 2020Pooled it
- Combined Lyon and Milan Scores Predict Gerd Management Outcome Better Than Either Score Alone or Their Individual Components.Alimentary pharmacology & therapeutics · 2025Article
- Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.Surgical endoscopy · 2024Article
- The role of magnetic sphincter augmentation in the gastroesophageal reflux disease treatment pathway: the gastroenterology perspective.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2023Article
- Safety and efficacy of magnetic sphincter augmentation dilation.Surgical endoscopy · 2021Article
- A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.Surgical endoscopy · 2020Article
- LINXWorld journal of clinical cases · 2020Article
- Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020Article
- Does Treatment of the Hiatus Influence the Outcomes of Magnetic Sphincter Augmentation for Chronic GERD?Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019Article
- Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies.Updates in surgery · 2018Review
- Comparison of the outcome of laparoscopic procedures for GERD.Updates in surgery · 2018Review
- Spotlight on the Linx™ Reflux Management System for the treatment of gastroesophageal reflux disease: evidence and research.Medical devices (Auckland, N.Z.) · 2018Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesMagnetic sphincter augmentation (MSA) is a surgical treatment option for patients with gastroesophageal reflux disease (GERD). MSA consistently improves quality of life, maintains freedom from PPIs, and objectively controls GERD. However, up to 24% of patients did not achieve these outcomes. We sought to identify factors predicting outcomes after MSA placement with the aim of refining selection criteria.
methodsWe retrospectively analyzed clinical, endoscopic, manometric, pH data, and intraoperative factors from two databases: Pivotal Trial (N = 99) and our prospectively maintained esophageal database (N = 71). A priori outcomes were defined as excellent (GERD-HRQL <5, no PPI, no esophagitis), good (GERD-HRQL 6-15, no PPI, grade A esophagitis), fair (GERD-HRQL 16 to 25, PPI use, grade B esophagitis), and poor (GERD-HRQL >25, PPI use, grade C/D esophagitis). Univariable and multivariable logistic regression analyses were performed to determine predictors of achieving an excellent/good outcome.
resultsA total of 170 patients underwent MSA with a median age of 53 years, [43-60] and a median BMI of 27 (IQR = 24-30). At baseline, 93.5% of patients experienced typical symptoms and 69% atypical symptoms. Median DeMeester score was 37.9 (IQR 27.9-51.2) with a structurally intact sphincter in 47%. Esophagitis occurred in 43%. At 48 [19-60] months after MSA, excellent outcomes were achieved in 47%, good in 28%, fair in 22%, and poor in 3%. Median DeMeester score was 15.6 (IQR = 5.8-26.6), esophagitis in 17.6% and daily PPI use in 17%. At univariable analysis, excellent/good outcomes were negatively impacted by BMI, preoperative LES residual pressure, Hill grade, and hiatal hernia. At multivariable analysis, BMI >35 (OR = 0.05, 0.003-0.78, p = 0.03), structurally defective LES (OR = 0.37, 0.13-0.99, p = 0.05), and preoperative LES residual pressure (OR = 0.89, 0.80-0.98, p = 0.02) were independent negative predictors of excellent/good outcome.
conclusionsMagnetic sphincter augmentation results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LES residual pressure may prevent this goal.
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Registered trials
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