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Endoscopy 2020; 52(06): 469-473
DOI: 10.1055/a-1124-3187
Innovations and brief communication

Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes

Pier Alberto Testoni
1   School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Sabrina Testoni
1   School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Giorgia Mazzoleni
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Giuseppe Pantaleo
3   UniSR-Social.Lab (Research Methods), Faculty of Psychology, Vita-Salute San Raffaele University, Milan, Italy
,
Maria Bernadette Cilona
1   School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
,
Giovanni Distefano
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Lorella Fanti
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Mario Antonelli
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
,
Sandro Passaretti
2   Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy
› Author AffiliationsTRIAL REGISTRATION: Single-Center, prospective, observational Study NCT03669874 at clinicaltrials.gov
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Referred to by:

Challenges for endoscopic antireflux proceduresEndoscopy 2020; 52(06): 431-432
DOI: 10.1055/a-1149-2032

See also:

Too early to aʼMUSE!Endoscopy 2021; 53(06): 664-664
DOI: 10.1055/a-1327-2359

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

Letter to this article:

Reply to Chandnani et al.Endoscopy 2021; 53(06): 665-665
DOI: 10.1055/a-1345-8648

 

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