Background & Aims: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Methods: We screened… Read more »
The effect of endoscopic fundoplication and proton pump inhibitors on baseline impedance and heartburn severity in GERD patients
BACKGROUND: Antireflux therapy may lead to recovery of impaired mucosal integrity in gastro-esophageal reflux disease (GERD) patients as reflected by an increase in baseline impedance. The study objective was to evaluate the effect of endoscopic fundoplication and proton pump inhibitor (PPI) PPI therapy on baseline impedance and heartburn severity in GERD patients. METHODS: Forty-seven GERD… Read more »
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,… Read more »
Transoral Incisionless Fundoplication: 2 Year Results from the Prospective Multicenter U.S. study
ABSTRACT The aim of this study was to assess prospectively 2-year outcomes of transoral incisionless fundoplication (TIF) in a multicenter setting. A 14 center U.S. registry was designed to evaluate the effects of the TIF 2.0 procedure on chronic gastroesophageal reflux disease (GERD) in over 100 patients. Primary outcome was symptom assessment. Secondary outcomes were proton pump inhibitor (PPI)… Read more »
Efficacy of Transoral Fundoplication for Treatment of Chronic Gastroesophageal Reflux Disease Incompletely Controlled With High-Dose PPI Therapy: a Randomized, Multicenter, Open Label, Crossover Study
BACKGROUND: The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF. METHODS: In seven United States centers, patients with hiatal hernia ≤ 2 cm and abnormal esophageal acid exposure (EAE)… Read more »
Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication
Background: Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. Methods: Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010… Read more »
Effect of transoral incisionless fundoplication on reflux mechanisms
OBJECTIVES: Transoral incisionless fundoplication (TIF) is a new endoscopic treatment option for gastroesophageal reflux disease (GERD). The mechanisms underlying the anti-reflux effect of this new procedure have not been studied. We therefore conducted this explorative study to evaluate the effect of TIF on reflux mechanisms, focusing on transient lower esophageal sphincter relaxations (TLESRs) and esophagogastric… Read more »
The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience
PURPOSE: This study aimed to assess the impact of transoral incisionless fundoplication (TIF) on patients with chronic gastroesophageal reflux disease (GERD) at 12-month follow-up. METHODS: Clinical outcomes of 100 consecutive patients with chronic GERD who underwent TIF between January 2010 and February 2011 were analyzed. RESULTS: There were no major complications reported. Esophageal acid exposure… Read more »
Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature
BACKGROUND: Gastroesophageal reflux disease (GERD) remains a significant problem for the medical community. Many endoluminal treatments for GERD have been developed with little success. Currently, transoral incisionless fundoplication (TIF) attempts to recreate a surgical fundoplication through placement of full-thickness polypropylene H-fasteners. This, the most recent procedure to gain FDA approval, has shown some promise in… Read more »
Three-year Results of a Multicenter Prospective Study of Transoral Incisionless Fundoplication
BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1… Read more »