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001-es BibID:BIBFORM105864
035-os BibID:(WOS)000553438000001 (Scopus)85088351873 (cikkazonosító)159
Első szerző:Bjelovic, Milos
Cím:Non-active implantable device treating acid reflux with a new dynamic treatment approach : 1-year results : RefluxStop device; a new method in acid reflux surgery obtaining CE mark / Miloš Bjelović, László Harsányi, Áron Altorjay, Zsolt Kincses, Peter Forsell, RefluxStop Clinical Investigation Study Group
Dátum:2020
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:BMC Surgery. - 20 : 1 (2020). -
További szerzők:Harsányi László Altorjay Áron Kincses Zsolt (1961-) (orvos) Fossel, Peter Reflux Stop Clinical Investigation Study Group
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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2.

001-es BibID:BIBFORM125714
035-os BibID:(Scopus)85201232492 (WoS)001290971500008
Első szerző:Harsányi László
Cím:Treating acid reflux without compressing the food passageway : 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study / László Harsányi, Zsolt Kincses, Joerg Zehetner, Áron Altorjay
Dátum:2024
ISSN:0930-2794
Megjegyzések:Introduction: RefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device. Methods: A prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD. Results: Available data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux. Conclusion: These results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop's dynamic physiologic interaction and non-encircling nature.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Dysphagia
Gas-bloating
Gastroesophageal reflux disease (GERD)
pH monitoring
RefluxStop
Surgery
Megjelenés:Surgical Endoscopy And Other Interventional Techniques. - 38 : 10 (2024), p. 6060-6069. -
További szerzők:Kincses Zsolt (1961-) (orvos) Zehetner, Joerg Altorjay Áron
Internet cím:Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
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