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

John G. Hunter, Peter J. Kahrilas, Reginald C W Bell, Erik B. Wilson, Karim S. Trad, James P. Dolan, Kyle A. Perry, Brant K. Oelschlager, Nathaniel J. Soper, Brad E. Snyder, Miguel A. Burch, W. Scott Melvin, Kevin M. Reavis, Daniel G. Turgeon, Eric S. Hungness, Brian S. Diggs

Research output: Contribution to journalArticle

70 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)324-333
Number of pages10
JournalGastroenterology
Volume148
Issue number2
DOIs
StatePublished - Feb 1 2015
Externally publishedYes

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Fundoplication
Omeprazole
Randomized Controlled Trials
Gastroesophageal Reflux
Proton Pump Inhibitors
Esophageal pH Monitoring
Digestive System Endoscopy
Therapeutics
Hiatal Hernia
Intention to Treat Analysis
Manometry
Barium
Deglutition
Placebos

Keywords

  • Esophagus
  • EsophyX
  • Stomach
  • TIF

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

Hunter, J. G., Kahrilas, P. J., Bell, R. C. W., Wilson, E. B., Trad, K. S., Dolan, J. P., ... Diggs, B. S. (2015). Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology, 148(2), 324-333. https://doi.org/10.1053/j.gastro.2014.10.009

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. / 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, W. Scott; Reavis, Kevin M.; Turgeon, Daniel G.; Hungness, Eric S.; Diggs, Brian S.

In: Gastroenterology, Vol. 148, No. 2, 01.02.2015, p. 324-333.

Research output: Contribution to journalArticle

Hunter, JG, Kahrilas, PJ, Bell, RCW, Wilson, EB, Trad, KS, Dolan, JP, Perry, KA, Oelschlager, BK, Soper, NJ, Snyder, BE, Burch, MA, Melvin, WS, Reavis, KM, Turgeon, DG, Hungness, ES & Diggs, BS 2015, 'Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial', Gastroenterology, vol. 148, no. 2, pp. 324-333. https://doi.org/10.1053/j.gastro.2014.10.009
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, W. Scott ; Reavis, Kevin M. ; Turgeon, Daniel G. ; Hungness, Eric S. ; Diggs, Brian S. / Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. In: Gastroenterology. 2015 ; Vol. 148, No. 2. pp. 324-333.
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AU - Wilson, Erik B.

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AU - Perry, Kyle A.

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N2 - 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.

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