Document Type
Journal Article
Publication Date
2-1-2015
Journal
Gastroenterology
Volume
Volume 148, Issue 2
Issue
2
Keywords
Adult; Aged; Female; Fundoplication; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Omeprazole; Postoperative Care; Proton Pump Inhibitors
Abstract
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) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar’s test or Fisher exact test was used to compare proportions.
Results
Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE.
Conclusions
The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.
Trial registration
Clinicaltrials.gov: NCT01647958.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
APA Citation
John G. Hunter, Peter J. Kahrilas, Reginald C.W. Bell, Erik B. Wilson, Karim S. Trad, James P. Dolan, Kyle A. Perry, Oelschlager, B.K., Soper, N.J., Snyder, B.E., Burch, M.A., Melvin, W.S., Reavis, K.M., Turgeon, D.G., Hungness, E.S., Diggs, B.S., Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial, Gastroenterology, Volume 148, Issue 2, February 2015, Pages 324-333.e5
Peer Reviewed
1
Open Access
1
Comments
Reproduced with permission of BioMed Central. BMC Gastroenterology.
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