Evidence map›Paper›PMID 18846406›Full record

Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2008

Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial.

Luigi Bonavina, Greta I Saino, Davide Bona, John Lipham, Robert A Ganz, Daniel Dunn, Tom DeMeester

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2008. 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 60 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 6 pooled it
2.1field-weighted citation impact, top 13% 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

60 citing papers in PubMed, 6 syntheses or guidelines pooled it, 146 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Magnetic Sphincter Augmentation After Gastric Surgery.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. Review
  13. Problems with repairing gut sphincters malfunctions.World journal of gastrointestinal surgery · 2024
    Article
  14. Article
  15. Refractory Gastroesophageal Reflux Disease: Diagnosis and Management.Journal of neurogastroenterology and motility · 2024
    Review
  16. Article
  17. Longer-term outcomes of gastroesophageal reflux disease treated with magnetic sphincter augmentation.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2023
    Article
  18. Article
  19. Article
  20. Article
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

7 authors at 4 institutions in 2 countries.

Luigi BonavinaIRCCS Policlinico San Donato, University of Milan, Via Morandi 30, 20097, San Donato Milanese, Milan, Italy. luigi.bonavina@unimi.it
Greta I Saino
Davide Bona
John Lipham
Robert A Ganz
Daniel Dunn
Tom DeMeester
University of Milan · ITAbbott Northwestern Hospital · USSouthern California University for Professional Studies · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy.

methodsPatients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus.

resultsOver a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12-434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred.

conclusionsLaparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.

Indexed as

AdultAgedEquipment SafetyEsophageal pH MonitoringEsophageal Sphincter, LowerEsophagoscopyFeasibility StudiesFemaleGastroesophageal RefluxHumansMagneticsMaleManometryMiddle AgedProspective StudiesProsthesis Design

Identifiers

PMID18846406
OpenAlexW2126705466

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.