Evidence map›Paper›PMID 34750704›Full record

ArticleSurgical endoscopy2022

Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis.

Daryl Ramai, Alexandra Shapiro, Mohamed Barakat, Antonio Facciorusso, Adriane Dull, Saurabh Chandan, Douglas G Adler

Abstract read
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In one paragraph

Article in Surgical endoscopy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  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. Review
  10. Article
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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

7 authors at 4 institutions in 2 countries.

Daryl RamaiDivision of Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA.
Alexandra ShapiroDepartment of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA.
Mohamed BarakatDivision of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA.
Antonio FacciorussoSection of Gastroenterology, Department of Medical Sciences, University of Foggia, 71122, Foggia, Italy.
Adriane DullDepartment of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA.
Saurabh ChandanDivision of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA.
Douglas G AdlerCenter for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA. dougraham2001@gmail.com.ORCID http://orcid.org/0000-0002-9512-8693
Brooklyn Hospital Center · USCHI Health Creighton University Medical Center - Bergan Mercy · USPorter Adventist Hospital · USUniversity of Foggia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database.

methodsWe analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021.

resultsDuring the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R

conclusionsAdverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.

Indexed as

EsophagoplastyGastroesophageal RefluxFundoplicationHumansTreatment OutcomeAdverse eventsGastroesophageal reflux diseaseObesityTransoral incisionless fundoplication

Identifiers

PMID34750704
OpenAlexW3214366297

What OpenQuestion holds

Textmetadata
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.