Format

Send to

Choose Destination
Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.

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

Author information

1
Department of Surgery, Oregon Health & Science University, Portland, Oregon. Electronic address: hunterj@ohsu.edu.
2
Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois.
3
SurgOne Foregut Institute, Englewood, Colorado.
4
Department of Surgery, University of Texas Health Science Center, Houston, Texas.
5
Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia; Reston Surgical Associates, Reston, Virginia.
6
Department of Surgery, Oregon Health & Science University, Portland, Oregon.
7
Department of Surgery, The Ohio State University, Columbus, Ohio.
8
Department of Surgery, University of Washington, Seattle, Washington.
9
Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
10
Department of Surgery, Oregon Health & Science University, Portland, Oregon; Department of Surgery, Oregon Clinic, Portland, Oregon.

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.

KEYWORDS:

Esophagus; EsophyX; Stomach; TIF

PMID:
25448925
DOI:
10.1053/j.gastro.2014.10.009
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center