Evidence map›Paper›PMID 29405886›Full record

Trial reportSurgical innovation2018

The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

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

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Surgical innovation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05579587 (Transoral Incisionless Fundoplication), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT05579587 withdrawnnot on this mapstarted 2024, after this paper: background citation

Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients

TypeobservationalSponsorBrigham and Women's HospitalRan2024 to 2025Enrolled0ConditionsGastroesophageal Reflux Disease (GERD), Laryngopharyngeal Reflux (LPR), Reflux Disease, Gastro-Esophageal, Motility DisorderArmsTransoral Incisionless Fundoplication
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  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. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: methodology and review of evidence.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
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  14. Review
  15. Article
  16. Review
  17. Article
  18. Functional outcomes of hybrid hiatal hernia repair.Journal of robotic surgery · 2023
    Article
  19. 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

10 authors.

Karim S Trad1 The George Washington University School of Medicine and Health Science, Washington, DC, USA.
William E Barnes3 Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
Elizabeth R Prevou2 The George Washington University Medical Faculty Associates, Washington, DC, USA.
Gilbert Simoni4 Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
Jennifer A Steffen2 The George Washington University Medical Faculty Associates, Washington, DC, USA.
Ahmad B Shughoury5 Saint Mary Medical Center, Hobart, IN, USA.
Mamoon Raza7 Indiana Medical Research, Elkhart, IN, USA.
Jeffrey A Heise9 Hancock Regional Hospital, Greenfield, IN, USA.
Mark A Fox10 Crossville Medical Group, Crossville, TN, USA.
Peter G Mavrelis5 Saint Mary Medical Center, Hobart, IN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuestions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0.

methodsA total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX

resultsOf 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001).

conclusionIn this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

Indexed as

FundoplicationAdultAgedCost-Benefit AnalysisCross-Over StudiesFemaleGastroesophageal RefluxHumansMaleMiddle AgedPostoperative ComplicationsProton Pump InhibitorsReoperationTreatment OutcomeProton Pump Inhibitorsatypical GERD symptomsEsophyXheartburnproton pump inhibitor (PPI)regurgitationtransoral incisionless fundoplication (TIF)

Identifiers

PMID29405886
PMCPMC5946656

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Registered trials

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.