Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

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 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

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. CONCLUSION: At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.

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 was normalized in 14/27 (52%) of patients who underwent 12-month pH testing. Seventy-four percent of all patients were off proton pump inhibitors versus 92% on daily proton pump inhibitors before TIF, P<0.001. Daily bothersome heartburn and regurgitation symptoms were eliminated in 66/85 (78%) and 48/58 (83%) of patients. Median reflux symptom index score was reduced from 20 (0 to 41) to 5 (0 to 44), P<0.001. Two patients reported de novo dysphagia and 1 patient reported bloating (scores 0 to 3). Six patients underwent revision; 5 laparoscopic Nissen fundoplication and 1 TIF. CONCLUSIONS: TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.

Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms.

BACKGROUND: A retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1-2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms. METHODS: Thirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with their current therapy or not willing to continue taking medication, underwent TIF using EsophyX at our community-based hospital. Follow-up assessments were completed in 28 patients. RESULTS: Median age of the study group was 57 (range = 23-77) years, BMI was 25.7 (18.3-36.4) kg/m(2), and 50% were female. All patients had documented chronic GERD for a median 5 (1-20) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 75% (21/28) of patients, and 21% (6/28) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF-2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the gastroesophageal (GE) junction (Hill grade I). There were no postoperative complications. At a median 14-months follow-up, 82% (23/28) of patients were off daily PPIs (64% completely off PPIs), and 68% (19/28) were satisfied with their current health condition compared to 4% before TIF. Median GERD Health-Related Quality of Life scores were significantly reduced to 4 (0-25) from 26 (0-45) before TIF (P < 0.001). Heartburn was eliminated in 65% (17/26) and improved by >50% in 86% (24/28) of patients. Regurgitation was eliminated in 80% (16/20) of patients. Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 63% (17/27) of patients as measured by Reflux Symptom Index scores. CONCLUSION: Our results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GERD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients.