Evidence map›Paper›PMID 26437027›Full record

ArticleJournal of laparoendoscopic & advanced surgical techniques. Part A2015

Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement.

Greta Saino, Luigi Bonavina, John C Lipham, Daniel Dunn, Robert A Ganz

Registry-linked trialOpen access · hybridAbstract readControlled Clinical TrialMulticenter Study
In one paragraph

Article in Journal of laparoendoscopic & advanced surgical techniques. Part A, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01058070 (An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter), which is not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01058070 nacompletednot on this map

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

TypeinterventionalSponsorTorax Medical IncorporatedRan2007 to 2013Enrolled44ConditionsGastroesophageal Reflux DiseaseArmsTorax Medical, Inc. LINX Reflux Management System
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 5 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
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  5. LINXSurgical endoscopy · 2017
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  17. Magnetic sphincter augmentation: considerations for use in Barrett's esophagus.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2023
    Article
  18. 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 · 2023
    Article
  19. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Greta Saino1 Division of General Surgery, IRCCS Policlinico San Donato, University of Milan Medical School , Milan, Italy .
Luigi Bonavina1 Division of General Surgery, IRCCS Policlinico San Donato, University of Milan Medical School , Milan, Italy .
John C Lipham2 Department of Surgery, Keck School of Medicine, University of Southern California , Los Angeles, California.
Daniel Dunn3 Division of Surgery, Abbot Northwestern Hospital , Minneapolis, Minnesota.
Robert A Ganz4 Minnesota Gastroenterology PA, Plymouth, Minnesota.
University of Milan · ITAbbott Northwestern Hospital · USMNGI Digestive Health · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here. PATIENTS AND

methodsA prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated.

resultsBetween February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point.

conclusionsBased on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.

Indexed as

MagnetsProstheses and ImplantsQuality of LifeAdultAgedEsophageal pH MonitoringEsophageal Sphincter, LowerFemaleFollow-Up StudiesGastroesophageal RefluxHumansLaparoscopyMaleMiddle AgedPilot ProjectsProspective StudiesProton Pump Inhibitors

Identifiers

PMID26437027
PMCPMC4624249
OpenAlexW1841919849

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.