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Surg Innov. 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.

Author information

1
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA ktrad@mfa.gwu.edu.
2
Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
3
Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
4
Saint Mary Medical Center, Hobart, IN, USA Internal Medicine Associates, Merrillville, IN, USA.
5
Indiana Medical Research, Elkhart, IN, USA Unity Surgical Hospital, Mishawaka, IN, USA.
6
Hancock Regional Hospital, Greenfield, IN, USA.
7
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA.
8
Crossville Medical Group, Crossville, TN, USA Cumberland Medical Center, Crossville, TN, USA.

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)

PMID:
24756976
PMCID:
PMC4361451
DOI:
10.1177/1553350614526788
[Indexed for MEDLINE]
Free PMC Article

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