Evidence map›Paper›PMID 32676727›Full record

Observational studySurgical endoscopy2021

Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication.

Luigi Bonavina, Thomas Horbach, Sebastian F Schoppmann, Janet DeMarchi

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Surgical endoscopy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01624506 (Observational Study of Anti-Reflux Surgery), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01624506 completednot on this map

Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication

TypeobservationalSponsorTorax Medical IncorporatedRan2010 to 2018Enrolled760ConditionsGERD, Gastroesophageal Reflux, Gastro Esophageal Reflux
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. 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
  11. 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

4 authors.

Luigi BonavinaDivision of General and Foregut Surgery, Department of Biomedical Sciences for Health, University of Milano, IRCCS Policlinico San Donato, Milano, Italy.
Thomas HorbachDepartment of Surgery, Schön Klinik Nürnberg Fürth, 90763, Fürth, Germany.
Sebastian F SchoppmannDepartment of Surgery, Medical University Vienna, 1090, Vienna, Austria.
Janet DeMarchiEthicon, Inc., Cincinnati, OH, USA. jdemarch@its.jnj.com.ORCID http://orcid.org/0000-0002-9095-4961

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMagnetic 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.

objectiveThe objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD.

methodsThis 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.

resultsBetween 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.

conclusionsThis 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.

Indexed as

FundoplicationLaparoscopyEsophageal Sphincter, LowerHumansMagnetic PhenomenaProspective StudiesQuality of LifeTreatment OutcomeAnti-reflux surgeryFundoplicationGERDLINXProton pump inhibitorsRegurgitation

Identifiers

PMID32676727
PMCPMC8195805

What OpenQuestion holds

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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.