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


CONCLUSIONS
At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA ktrad@mfa.gwu.edu.
Karim S
KS
Trad
Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
William E
WE
Barnes
Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
Gilbert
G
Simoni
Saint Mary Medical Center, Hobart, IN, USA Internal Medicine Associates, Merrillville, IN, USA.
Ahmad B
AB
Shughoury
Saint Mary Medical Center, Hobart, IN, USA Internal Medicine Associates, Merrillville, IN, USA.
Peter G
PG
Mavrelis
Indiana Medical Research, Elkhart, IN, USA Unity Surgical Hospital, Mishawaka, IN, USA.
Mamoon
M
Raza
Hancock Regional Hospital, Greenfield, IN, USA.
Jeffrey A
JA
Heise
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA.
Daniel G
DG
Turgeon
Crossville Medical Group, Crossville, TN, USA Cumberland Medical Center, Crossville, TN, USA.
Mark A
MA
Fox
D000368:Aged; D005260:Female; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome
D054328:Proton Pump Inhibitors
EsophyX; extraesophageal GERD symptoms; heartburn; proton pump inhibitor (PPI); regurgitation; transoral incisionless fundoplication (TIF)