Evidence map›Paper›PMID 27655380›Full record

Trial reportSurgical endoscopy2017

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

Karim S Trad, Mark A Fox, Gilbert Simoni, Ahmad B Shughoury, Peter G Mavrelis, Mamoon Raza, Jeffrey A Heise, William E Barnes

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Surgical endoscopy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Transoral incisionless fundoplication as rescue therapy for gastroesophageal reflux in a lung transplant recipient.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  7. Article
  8. Review
  9. Hybrid hiatal hernia repair: is it cost-effective?Journal of robotic surgery · 2022
    Article
  10. Review
  11. Article
  12. Article
  13. Endoscopic and Surgical Treatments for Achalasia: Who to Treat and How?Gastroenterology clinics of North America · 2020
    Review
  14. Review
  15. The evolution of TIF: transoral incisionless fundoplication.Therapeutic advances in gastroenterology · 2020
    Review
  16. Article
  17. Article
  18. Article
  19. Endoscopic Treatments of GERD.Current treatment options in gastroenterology · 2018
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Karim S TradThe George Washington University School of Medicine and Health Sciences, Washington, DC, USA. ktrad@mfa.gwu.edu.ORCID 0000-0002-9149-707X
Mark A FoxCrossville Medical Group, Crossville, TN, USA.
Gilbert SimoniAdvanced Gastroenterology, Inc., Thousand Oaks, CA, USA.
Ahmad B ShughourySaint Mary Medical Center, Hobart, IN, USA.
Peter G MavrelisSaint Mary Medical Center, Hobart, IN, USA.
Mamoon RazaIndiana Medical Research, Elkhart, IN, USA.
Jeffrey A HeiseHeartburn Center/Rehabilitation Department, Hancock Regional Hospital, Greenfield, IN, USA.
William E BarnesLivingston Hospital and Healthcare Services, Inc., Salem, KY, USA.
St. Mary Medical Center · USAdvanced Dermatology · USCumberland Medical Center · USElkhart Clinic · USGeorge Washington University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFour randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX

methodsThe 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.

resultsAt 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.

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

Indexed as

AdultAgedChronic DiseaseCross-Over StudiesEsophagitis, PepticFemaleFundoplicationGastroesophageal RefluxHernia, HiatalHumansMaleMiddle AgedProton Pump InhibitorsQuality of LifeTime FactorsTreatment OutcomeProton Pump InhibitorsAtypical symptomsGERDHeartburnRegurgitationTIFTransoral fundoplication

Identifiers

PMID27655380
PMCPMC5443856
OpenAlexW2522987622

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.