Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 148; no. 2; pp. 324 - 333.e5
• Main Authors: Hunter, John G, Kahrilas, Peter J, Bell, Reginald C.W, Wilson, Erik B, Trad, Karim S, Dolan, James P, Perry, Kyle A, Oelschlager, Brant K, Soper, Nathaniel J, Snyder, Brad E, Burch, Miguel A, Melvin, William Scott, Reavis, Kevin M, Turgeon, Daniel G, Hungness, Eric S, Diggs, Brian S
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2015
• Subjects: Adult; Aged; Esophagus; EsophyX; Female; Fundoplication - methods; Gastroenterology and Hepatology; Gastroesophageal Reflux - therapy; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Omeprazole - therapeutic use; Postoperative Care; Proton Pump Inhibitors - therapeutic use; Stomach; TIF; Stomach; EsophyX; EGD; Reflux Disease Questionnaire; ITT; PPI; esophagogastroduodenoscopy; proton pump inhibitor; Esophagus; TIF; GERD; TF; intention to treat; transoral fundoplication; gastroesophageal reflux disease; RDQ
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2014.10.009

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.