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Surg Endosc. 2017 Jun;31(6):2498-2508. doi: 10.1007/s00464-016-5252-8. Epub 2016 Sep 21.

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm.

Author information

1
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA. ktrad@mfa.gwu.edu.
2
The George Washington University Medical Faculty Associates, 1800 Town Center Drive, #218, Reston, VA, 20190, USA. ktrad@mfa.gwu.edu.
3
Crossville Medical Group, Crossville, TN, USA.
4
Cumberland Medical Center, Crossville, TN, USA.
5
Advanced Gastroenterology, Inc., Thousand Oaks, CA, USA.
6
Saint Mary Medical Center, Hobart, IN, USA.
7
Internal Medicine Associates, Merrillville, IN, USA.
8
Indiana Medical Research, Elkhart, IN, USA.
9
Unity Surgical Hospital, Mishawaka, IN, USA.
10
Heartburn Center/Rehabilitation Department, Hancock Regional Hospital, Greenfield, IN, USA.
11
Livingston Hospital and Healthcare Services, Inc., Salem, KY, USA.

Abstract

BACKGROUND:

Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure.

METHODS:

The TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis.

RESULTS:

At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups.

CONCLUSION:

This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

KEYWORDS:

Atypical symptoms; GERD; Heartburn; Regurgitation; TIF; Transoral fundoplication

PMID:
27655380
PMCID:
PMC5443856
DOI:
10.1007/s00464-016-5252-8
[Indexed for MEDLINE]
Free PMC Article

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