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DOI: 10.1055/a-1124-3187
Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes
TRIAL REGISTRATION: Single-Center, prospective, observational Study NCT03669874 at clinicaltrials.gov
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Abstract
Background Transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) is a new intervention for the treatment of the gastroesophageal reflux disease (GERD). The aim of this study was to assess the 12-month clinical, functional, and endoscopic effects of TIF by MUSE.
Methods Patients undergoing MUSE completed the GERD-Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, and underwent endoscopy, esophageal 24-hour pH-impedance recording, and high resolution manometry (HRM) before the TIF procedure and 12 months later, or after 6 months for HRM.
Results Among the 37 patients treated, esophageal intubation was not possible in one and esophageal perforation occurred in another. Clinical and endoscopic follow-up at 12 months was completed in 20 patients, with significant improvements in GERD-HRQL, RSI, heartburn, regurgitation scores, and proton pump inhibitor (PPI) consumption observed. One patient required surgery for persisting symptoms. Functional follow-up was possible in 13 patients and showed no significant improvements in the analyzed parameters.
Conclusions TIF with MUSE significantly improved symptoms at 1-year follow-up, allowing the consumption of PPIs to be stopped or halved in 90 % of patients.
Publication History
Received: 12 June 2019
Accepted: 17 January 2020
Article published online:
18 March 2020
© Georg Thieme Verlag KG
Stuttgart · New York
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References
- 1 Huang X, Chen S, Zhao H. et al. Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surg Endosc 2017; 31: 1032-1044
- 2 McCarty TR, Itidiare M, Njei B. et al. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy 2018; 50: 708-725
- 3 Kauer WK, Roy-Shapira A, Watson D. et al. Preclinical trial of a modified gastroscope that performs a true anterior fundoplication for the endoluminal treatment of gastroesophageal reflux disease. Surg Endosc 2009; 23: 2728-2731
- 4 Gweon TG, Matthes K. Prospective, randomized ex vivo trial to assess the ideal stapling site for endoscopic fundoplication with Medigus ultrasonic surgical endostapler. Gastroenterol Res Pract 2016; 2016: 3161738
- 5 Roy-Shapira A, Bapaye A, Date S. et al. Trans-oral anterior fundoplication: 5-year follow-up of pilot study. Surg Endosc 2015; 29: 3717-3721
- 6 Stefanidis D, Hope WW, Kohn GP. et al. SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc 2010; 11: 2647-2669
- 7 Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 2007; 20: 130-134
- 8 Schindler A, Mozzanica F, Ginocchio D. et al. Reliability and clinical validity of the Italian Reflux Symptom Index. J Voice 2010; 24: 354-358
- 9 Coronel MA, Bernardo WM, de Moura DTH. et al. The efficacy of the different endoscopic treatments versus sham, pharmacologic or surgical methods for chronic gastroesophageal reflux disease: a systematic review and meta-analysis. Arq Gastroenterol 2018; 55: 296-305
- 10 Testoni PA, Testoni S, Mazzoleni G. et al. Long-term efficacy of transoral incisionless fundoplication with Esophyx (TIF 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc 2015; 29: 2770-2780
- 11 Trad K, Fox MA, Simoni G. et al. Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surg Endosc 2017; 31: 2498-2508
- 12 Stefanidis G, Viazis N, Kotsikoros N. et al. Long-term benefit of transoral incisionless fundoplication using the Esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Dis Esophagus 2017; 30: 1-8
- 13 Kim HJ, Kwon CI, Kessler WR. et al. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device. Surg Endosc 2016; 30: 3402-3408
- 14 Chimukangara M, Jalilvand AD, Melvin WS. et al. Long-term reported outcomes of transoral incisionless fundoplication: an 8-year cohort study. Surg Endosc 2019; 33: 1304-1309
- 15 Garg SK, Gurusamy KS. Laparoscopic fundoplication surgery versus medical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev 2015; (11) CD003243