Evidence map›Paper›PMID 24756976›Full record

Trial reportSurgical innovation2015

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial.

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

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Surgical innovation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07749352 (One-year Clinical Outcomes of Endoscopic Cardia Banding Plication for Refractory Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy), which is not on this map. Cited by 64 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 4 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.

NCT07749352 nacompletednot on this mapstarted 2022, after this paper: background citation

One-year Clinical Outcomes of Endoscopic Cardia Banding Plication for Refractory Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy: a Single-center Retrospective Cohort Study

TypeinterventionalSponsorChina-Japan Friendship HospitalRan2022 to 2025Enrolled47ConditionsGastroesophageal Reflux Disease (GERD)Armsendoscopic cardia banding plication
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 more citing papers are in PubMed but not listed here.

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

9 authors.

Karim S TradThe George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA ktrad@mfa.gwu.edu.
William E BarnesLivingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
Gilbert SimoniAdvanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
Ahmad B ShughourySaint Mary Medical Center, Hobart, IN, USA Internal Medicine Associates, Merrillville, IN, USA.
Peter G MavrelisSaint Mary Medical Center, Hobart, IN, USA Internal Medicine Associates, Merrillville, IN, USA.
Mamoon RazaIndiana Medical Research, Elkhart, IN, USA Unity Surgical Hospital, Mishawaka, IN, USA.
Jeffrey A HeiseHancock Regional Hospital, Greenfield, IN, USA.
Daniel G TurgeonThe George Washington University School of Medicine and Health Sciences, Washington, DC, USA Reston Surgical Associates, Reston, VA, USA.
Mark A FoxCrossville Medical Group, Crossville, TN, USA Cumberland Medical Center, Crossville, TN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias.

methodsBetween June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis.

resultsOf 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs.

conclusionAt 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.

Indexed as

AgedFemaleFundoplicationGastroesophageal RefluxHumansMaleMiddle AgedProton Pump InhibitorsTreatment OutcomeProton Pump InhibitorsEsophyXextraesophageal GERD symptomsheartburnproton pump inhibitor (PPI)regurgitationtransoral incisionless fundoplication (TIF)

Identifiers

PMID24756976
PMCPMC4361451

What OpenQuestion holds

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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.