The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective

Background.  Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. Methods. A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid… Read more »

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

BACKGROUND: Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX®device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure. METHODS: The TF EsophyX versus Medical… 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 »

Transoral Fundoplication vs. Proton Pump Inhibitor Therapy For Treatment of Chronic Gastroesophageal Reflux: Short-term Results From a Multicenter, Randomized, Open Label Clinical Trial

BACKGROUND & AIM:  Transoral fundoplication (TF) has previously been shown to be a safe and effective treatment alternative for a selected gastroesophageal reflux disease (GERD) patient population. The aim of this prospective, multicenter, open-label, randomized study was to compare the safety and efficacy of the TF procedure against maximum dose PPI in controlling the chronic… Read more »

A Prospective Multicenter Registry of Patients with Chronic Gastroesophageal Reflux Disease Receiving Transoral Incisionless Fundoplication

BACKGROUND: This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. STUDY DESIGN: Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures… Read more »

Transoral incisionless fundoplication for treatment of gastroesophageal reflux disease in clinical practice

BACKGROUND: Transoral incisionless fundoplication is a recently introduced endoluminal technique for the treatment of gastroesophageal reflux disease (GERD). The objective of this study was to determine outcomes in chronic GERD patients who were referred for surgical management. METHODS: A cohort of 38 patients underwent transoral incisionless fundoplication (TIF) in a tertiary care setting. Pre- and… Read more »

Transoral incisionless esophago-gastric fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice

This retrospective study evaluated clinical outcomes in 124 consecutive gastroesophageal reflux disease (GERD) patients who underwent transoral incisionless fundoplication (TIF) at 2 community hospitals. Out of 123 patients treated successfully, 110 gave consent (74% female, median age 60 [range 21-87] years, body mass index 27.5 [19.0-47.9]). At a median 7-month follow-up (range 5-17), typical and… Read more »

Laparoscopic Nissen fundoplication after failed EsophyX fundoplication

BACKGROUND: Reflux control may be ineffective in a substantial number of patients after endoluminal EsophyX fundoplication for gastro-oesophageal reflux disease. Subsequent laparoscopic Nissen fundoplication (LNF) might be required to relieve symptoms. The aim of this study was to evaluate the outcome of LNF after previous EsophyX fundoplication. METHODS: EsophyX failure was defined as recurrence or… Read more »