Evidence map›Paper›PMID 42000769›Full record

ArticleScientific reports2026

Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries.

Sebastian F Schoppmann, Joerg Zehetner, Moustafa Elshafei, Thorsten Lehmann, Ahmed Ahmed, Naim Fakih-Gomez, Joy Feka, Fergus Noble, Nicholas Boyle, Maria Eugenia Barrios Carvajal and 14 more

Abstract readMulticenter Study
In one paragraph

Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

24 authors.

Sebastian F SchoppmannSurgical Oncology, Department of Surgery, Upper-GI-Service, Medical University of Vienna, Vienna, Austria. sebastian.schoppmann@meduniwien.ac.at.
Joerg ZehetnerDepartment of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
Moustafa ElshafeiDepartment of General and Visceral Surgery, Marien Hospital Mainz, Mainz, Germany.
Thorsten LehmannDepartment of Visceral Surgery, Klinikum Friedrichshafen GmbH, Friedrichshafen, Germany.
Ahmed AhmedDepartment of Surgery and Cancer, Imperial College London, London, UK.
Naim Fakih-GomezBariatric & Upper Gastrointestinal Department, Chelsea & Westminster Hospital, London, UK.
Joy FekaSurgical Oncology, Department of Surgery, Upper-GI-Service, Medical University of Vienna, Vienna, Austria.
Fergus NobleGeneral and Oesophagogastric (OG) Surgery, University Hospital Southampton, Southampton, UK.
Nicholas BoyleRefluxUK LTD, King Edward VII Hospital, London, UK.
Maria Eugenia Barrios CarvajalDepartment of General and Digestive Surgery, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Alberto Hernández MatiasDepartment of General and Digestive Surgery, Hospital Universitario de Getafe, Madrid, Spain.
J Daniel Sánchez LópezDepartment of General and Digestive Surgery, Hospital Universitario Infanta Sofía, Madrid, Spain.
Marta Cuadrado AyusoFEA Department of General and Digestive Surgery, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Beatriz Guil OrtizFEA Department of General and Digestive Surgery, Hospital Universitario Canarias, Santa Cruz de Tenerife, Spain.
Carlos Miliani MolinaDepartment of Geneal and Digestive Surgery, Hospital Universitario Fuenlabrada, Madrid, Spain.
Carlos Moreno SanzDepartment of Surgery Hospital General La Mancha-Centro, Alcázar de San Juan, Spain.
Gabriele PozzoDepartment of Surgery, Ospedale Santa Croce di Moncalieri, Moncalieri TO, Italy.
Maurizio PavanelloOspedale - ULSS 2 Marca Trevigiana, Conegliano, Italy.
Adolfo RenziOspedale Buon Consiglio - Fatebenefratelli Napoli, Napoli, Italy.
Davide BonaIRCCS Ospedale Galeazzi - Sant'Ambrogio, Milano, Italy.
Leonardo VincentiIRCCS Saverio de Bellis, Castellana Grotte, Bari, Italy.
Luigi BonavinaDivision of Foregut Surgery, Department of Pharmacy and Health Sciences and Nutrition, University of Calabria, A.O. di Cosenza "SS. Annunziata", Milano, Italy.
Yves BorbelyDepartment of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.
John C LiphamDivision of Upper GI and General Surgery, Keck School of Medicine of USC, Los Angeles, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

RefluxStop surgery aims to restore a functional anti-reflux barrier in gastroesophageal reflux disease (GERD) without encircling the esophagus, purportedly limiting dysphagia and gas-bloating. This report presents safety outcomes from 602 patients at 22 centers across six European countries and up to 6.75 years follow-up (mean [SD] 2 [1.25] years). Serious safety outcomes and reoperation occurred in 1.99% (12/602), all satisfactorily resolved. Thereof, two-thirds were reherniations (1.33%), which manifested from total disruption of crural repair, resolved by straightforward fundic repositioning and redo hiatal repair with RefluxStop unaffected in its pouch. Non-operative safety events included 4/602 (0.66%) cases of asymptomatic erosion (without action) in the early postoperative phase (4 weeks) as the learning curve of a new procedure. Dilatation for new-onset dysphagia was performed in one patient. This report presents an analysis focused on safety data from the largest independent RefluxStop study to date (n = 602). Despite inter-surgeon variability, the learning curve for a new procedure, and sizable proportions of large hernia and/or dysmotility patients, results show low rates of serious safety outcomes with reoperations occurring in <2%. The overall experience of the RefluxStop Evaluation Group demonstrated a consistent and favorable mid-to-long-term safety profile for RefluxStop in real-world surgical treatment of GERD.

Indexed as

FundoplicationGastroesophageal RefluxAdultAgedEuropeFemaleHumansMaleMiddle AgedPostoperative ComplicationsReoperationTreatment Outcome

Identifiers

PMID42000769
PMCPMC13254397

What OpenQuestion holds

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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.