Evidence map›Paper›PMID 34799745›Full record

ArticleSurgical endoscopy2022

Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years.

Sabrina Gloria Giulia Testoni, Maria Bernadette Cilona, Giorgia Mazzoleni, Lorella Fanti, Emanuela Ribichini, Giulia Martina Cavestro, Dario Esposito, Edi Viale, Chiara Notaristefano, Raffaella Alessia Zuppardo and 3 more

Registry-linked trialAbstract read
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In one paragraph

Article in Surgical endoscopy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03669874 (Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT03669874 recruitingnot on this map

Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

TypeobservationalSponsorIRCCS San RaffaeleRan2015 to 2026Enrolled80ConditionsGastro-esophageal Reflux, Endoscopic FundoplicationArmsEndoscopic fundoplication
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: methodology and review of evidence.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  4. Article
  5. Review
  6. 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

13 authors at 2 institutions in 1 country.

Sabrina Gloria Giulia TestoniDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Maria Bernadette CilonaDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Giorgia MazzoleniDivision of Gastrointestinal Endoscopy, Treviglio-Caravaggio Hospital, ASST Bergamo Ovest, Treviglio, Italy.
Lorella FantiDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Emanuela RibichiniDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Giulia Martina CavestroDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Dario EspositoDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Edi VialeDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Chiara NotaristefanoDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Raffaella Alessia ZuppardoDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Francesco AzzoliniDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Sandro PassarettiDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Pier Alberto TestoniDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy. testoni.pieralberto@hsr.it.ORCID http://orcid.org/0000-0003-0900-3155
Vita-Salute San Raffaele University · ITAzienda Ospedaliera Treviglio · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE.

methodsForty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis).

resultsTIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year.

conclusionTIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. CLINICALTRIALS: GOV: ID: NCT03669874.

Indexed as

Esophagitis, PepticGastroesophageal RefluxAlprostadilFundoplicationHumansProton Pump InhibitorsQuality of LifeTreatment OutcomeUltrasonicsAlprostadilProton Pump InhibitorsGastro-esophageal reflux diseaseMedigus Ultrasonic Surgical Endostapler (MUSE)Transoral incisionless fundoplication

Identifiers

PMID34799745
OpenAlexW3211491828

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.