Evidence map›Paper›PMID 25823768›Full record

Trial reportThe American journal of gastroenterology2015

Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease.

Bart P L Witteman, Jose M Conchillo, Nicolaas F Rinsma, Bark Betzel, Andrea Peeters, Ger H Koek, Laurents P S Stassen, Nicole D Bouvy

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05570448 (Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation), which is not on this map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT05570448 narecruitingnot on this mapstarted 2022, after this paper: background citation

Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)

TypeinterventionalSponsorMidwest Veterans' Biomedical Research FoundationRan2022 to 2027Enrolled36ConditionsGastro Esophageal RefluxArmsARAT, Sham intervention (control)
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. 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
  7. Article
  8. Article
  9. Article
  10. Problems with repairing gut sphincters malfunctions.World journal of gastrointestinal surgery · 2024
    Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Antireflux band mucosectomy: a novel minimally invasive approach for the treatment of refractory gastroesophageal reflux disease.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2022
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Bart P L Witteman1] Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands [2] Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
Jose M ConchilloDepartment of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Nicolaas F RinsmaDepartment of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Bark BetzelDepartment of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
Andrea PeetersDepartment of Clinical Epidemiolgy and Medical Technology Assessment, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Ger H KoekDepartment of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Laurents P S StassenDepartment of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Nicole D BouvyDepartment of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Maastricht University Medical Centre · NLRijnstate Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTransoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence.

methodsPatients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months.

resultsA total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%.

conclusionAlthough TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.

Indexed as

AdultAgedEsophagitis, PepticEsophagoscopyFollow-Up StudiesFundoplicationGastroesophageal RefluxGastroscopyHumansMiddle AgedProton Pump InhibitorsQuality of LifeResearch DesignTreatment OutcomeProton Pump Inhibitors

Identifiers

PMID25823768
OpenAlexW2048885015

What OpenQuestion holds

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Read underepoch 390

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.