Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial

Authors

Karim S. Trad, George Washington UniversityFollow
William E. Barnes, Livingston Hospital, Salem, KY
Gilbert Simoni, Advanced Gastroenterology, Inc., Thousand Oaks, CAFollow
Ahmad B. Shughoury, Saint Mary Medical Center, Hobart, IN
Peter G. Mavrelis, Saint Mary Medical Center, Hobart, IN
Mamoon Raza, Indiana Medical Research, Elkhart, IN
Jeffrey Heise, Hancock Regional Hospital, Greenfield, IN
Daniel G. Turgeon, Reston Surgical Associates, Reston, VA
Mark A. Fox, Crossville Medical Group, Crossville, TN

Document Type

Journal Article

Publication Date

4-2014

Journal

Surgical Innovation

Volume

22

Issue

1

Inclusive Pages

26-40

DOI

10.1177/1553350614526788

Abstract

Background. Incomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias.

Methods. Between June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX₂ device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis.

Results. Of 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs.

Conclusion. At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.

Comments

Reproduced with permission of Sage Publishers, Surgical Innovation.

Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial 3.0 License

APA Citation

Trad, K.S., Barnes, W.E., Simoni, G., Shughoury, A.B., Mavrelis, P.G. et al. (2014). Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial. Surgical Innovation.

Peer Reviewed

1

Open Access

1