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Published in: Surgical Endoscopy 5/2009

Open Access 01-05-2009

Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX

Authors: Guy-Bernard Cadière, Nathalie Van Sante, Jaime E. Graves, Anna K. Gawlicka, Amin Rajan

Published in: Surgical Endoscopy | Issue 5/2009

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Abstract

Background

A feasibility study (n = 19) evaluated the safety and initial efficacy of transoral incisionless fundoplication (TIF) for the treatment of gastroesophageal disease (GERD). The results at 1 year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia. This study was designed to evaluate the long-term safety and durability of TIF.

Methods

Fourteen patients (50% female; median age, 34 years) completed the 2-year follow-up assessment tests. Three patients were excluded from the study after 1 year because two of them underwent retreatment and one was lost to follow-up.

Results

At 2 years, no adverse events related to TIF were reported. A ≥50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (p < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared with baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced complete cure (29%) or remission (50%) of GERD at 2 years after TIF.

Conclusion

The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis, ≤2 cm hiatal hernia, and daily dependence on PPIs.
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Metadata
Title
Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX
Authors
Guy-Bernard Cadière
Nathalie Van Sante
Jaime E. Graves
Anna K. Gawlicka
Amin Rajan
Publication date
01-05-2009
Publisher
Springer-Verlag
Published in
Surgical Endoscopy / Issue 5/2009
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-009-0384-8

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