Evidence map›Paper›PMID 40696212›Full record

Trial reportSurgical endoscopy2025

Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: a prospective multicenter trial of safety and effectiveness.

László Harsányi, Zsolt Kincses, Milan Veselinović, Joerg Zehetner, Áron Altorjay

Abstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
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  5. 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.

László HarsányiDepartment of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary. harsanyi.laszlo@semmelweis.hu.
Zsolt KincsesThe Department of Surgery Kenezy Campus, Clinical Center of the University of Debrecen Teaching Hospital, Debrecen, Hungary.
Milan VeselinovićDepartment of Minimally Invasive Upper Digestive Surgery, University Hospital for Digestive Surgery-First Surgical Hospital, Clinical Center of Serbia, Belgrade, Serbia.
Joerg ZehetnerDepartment of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
Áron AltorjaySurgical Department, Fejér County Szent György University Teaching Hospital, Székesfehérvár, Hungary.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRefluxStop surgery corrects all three components of the anti-reflux barrier without affecting the food passageway. Long-term 5-year safety and effectiveness clinical outcomes are presented from the RefluxStop CE mark trial, used in an FDA PMA submission. This comprehensive and meticulously controlled data are, therefore, presented across multiple reports with other outcomes in a separate complementary article.

methodsA prospective, single-arm, multicenter clinical study was conducted to investigate RefluxStop surgery in 50 adults with chronic GERD, PPI use, GERD-HRQL score, 24-h pH testing, contrast-swallow x-ray, and serious/non-serious AEs presented.

resultsForty-four (n = 44) subjects completed 5-year follow-up, whereof 91% underwent pH testing and contrast-swallow x-ray. Three subjects were withdrawn due to COVID-19 (two deaths and one long-COVID), all well-treated beforehand, at 3-4 years. PPI usage (including COVID-19 subjects) in 1/47 (2.1%). The median (IQR) total GERD-HRQL score improved by 90% (72-98%) from a baseline of 29.5 (33.0-24.0) to 3.0 (0.5-7.5) at 5 years (p < 0.001) and 24-h pH monitoring results improved by 90.4% to a mean total acid exposure time (pH < 4) of 1.57% from 16.35% at baseline (p < 0.001). No cases (0%) of device explantation, migration/erosion, or esophageal dilatation occurred during the study. Five-year contrast-swallow x-ray showed zero (0%) dislocations, migrations, or re-herniations. Five subjects (n = 5) experienced serious AEs of which all were resolved. Only two procedure-related AEs occurred between 1 and 5 years, one moderate dyspepsia and one mild dysphagia, subsequently resolved.

conclusionThe RefluxStop procedure demonstrated exceptional long-term 5-year outcomes. Only one subject took PPIs at follow-up. Both median GERD-HRQL scores and mean 24-h pH results improved by > 90% from baseline (p = 0.001). No device-related AEs, explantations, or migrations occurred during the 5-year study. Only two procedure-related AEs occurred between 1 and 5 years, one dyspepsia and one mild dysphagia (resolved). These objective and patient-reported results were robustly maintained from previously published 1- to 4-year data.

Indexed as

Gastroesophageal RefluxAdultAgedEsophageal pH MonitoringFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment Outcome24-h pH monitoringAntireflux surgeryDysphagiaGastroesophageal reflux diseaseProton pump inhibitorsQuality of life

Identifiers

PMID40696212
PMCPMC12408713

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Registered trials

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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.