Surgical endoscopy · 2021
Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Ramai Daryl, Shapiro Alexandra, Barakat Mohamed, Facciorusso Antonio, Dull Adriane, Chandan Saurabh, Adler Douglas G
Аннотация
BACKGROUND: Transoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database.
METHODS: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021.
RESULTS: During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), and pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%).
CONCLUSIONS: Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.
METHODS: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021.
RESULTS: During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), and pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%).
CONCLUSIONS: Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.