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Randomized Controlled Trial
. 2015 Feb;22(1):26-40.
doi: 10.1177/1553350614526788. Epub 2014 Apr 21.

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial

Karim S Trad  1 , William E Barnes  2 , Gilbert Simoni  3 , Ahmad B Shughoury  4 , Peter G Mavrelis  4 , Mamoon Raza  5 , Jeffrey A Heise  6 , Daniel G Turgeon  7 , Mark A Fox  8
Affiliations
Randomized Controlled Trial

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial

Karim S Trad et al. Surg Innov. 2015 Feb.

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.

Keywords: EsophyX; extraesophageal GERD symptoms; heartburn; proton pump inhibitor (PPI); regurgitation; transoral incisionless fundoplication (TIF).

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Trad and Dr Simoni have reported that they have a consulting agreement with EndoGastric Solutions. Dr Trad, Dr Barnes, Dr Simoni, Dr Shughoury, Dr Mavrelis, Dr Raza, Dr Heise, Dr Turgeon, and Dr Fox reported that their institutions have received grant for research from EndoGastric Solutions for pre- and postoperative testing, TIF procedure, medications, and support for study coordinator.

Figures

Figure 1.
Figure 1.
Screening assessments of study patients.
Figure 2.
Figure 2.
CONSORT flowchart of study patients. Abbreviations: PPIs, proton pump inhibitors; TIF, transoral incisionless fundoplication.
Figure 3.
Figure 3.
(A) Elimination of daily troublesome atypical symptoms as evaluated by RSI questionnaires at 6-month follow-up. (B) PPI use before TIF and at 6-month follow-up. (C) Quality-of-life scores in patients back on some form of PPI regimen. (D) Rate of healing or reduction of reflux esophagitis in both treatment arms. (E) Elimination of daily troublesome heartburn as evaluated by GERD-HRQL questionnaires. Abbreviations: GERD-HRQL, gastroesophageal reflux disease health-related quality of life; PPIs, proton pump inhibitors; RDQ, Reflux Disease Questionnaire; RSI, Reflux Symptom Index; TIF, transoral incisionless fundoplication.
Figure 4.
Figure 4.
(A) Patient satisfaction with current health condition as evaluated by GERD-HRQL questionnaire. (B) Individual total GERD-HRQL scores in all patients before treatments and at 6-month follow-up. (C) Individual total heartburn scores in all patients before treatments and at 6-month follow-up. (D) Individual total RSI scores in all patients before treatments and at 6-month follow-up. Abbreviations: GERD-HRQL, gastroesophageal reflux disease health-related quality of life; PPIs, proton pump inhibitors; RSI, reflux symptom index; TIF, transoral incisionless fundoplication. Red lines represent improvement in the mean scores.
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