Evidence map›Paper›PMID 18443855›Full record

ArticleWorld journal of surgery2008

Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.

Guy-Bernard Cadière, Michel Buset, Vinciane Muls, Amin Rajan, Thomas Rösch, Alexander J Eckardt, Joseph Weerts, Boris Bastens, Guido Costamagna, Michele Marchese and 6 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in World journal of surgery, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
10.5field-weighted citation impact, top 1% 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.

NCT01025076 phase2completednot on this mapstarted 2009, after this paper: background citation

Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

TypeinterventionalSponsorUniversity of AlbertaRan2009 to 2012Enrolled14ConditionsMorbid ObesityArmsStomaphyX
NCT01025739 phase2withdrawnnot on this mapstarted 2010, after this paper: background citation

Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

TypeinterventionalSponsorUniversity of AlbertaRan2010 to 2011Enrolled0ConditionsGastroesophageal Reflux Disease (GERD)ArmsEsophyX™ system with SerosaFuse fasteners
NCT03357809 nasuspendednot on this mapstarted 2017, after this paper: background citation

Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

TypeinterventionalSponsorHospital St. Joseph, Marseille, FranceRan2017 to 2023Enrolled15ConditionsGERD, Gastro Esophageal RefluxArmsEndoscopic mucosal resection
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 2 syntheses or guidelines pooled it, 157 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Endoluminal fundoplication (ELF) for GERD using EsophyX: a 12-month follow-up in a single-center experience.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2010
    Trial
  9. Article
  10. Article
  11. Problems with repairing gut sphincters malfunctions.World journal of gastrointestinal surgery · 2024
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. The evolution of TIF: transoral incisionless fundoplication.Therapeutic advances in gastroenterology · 2020
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 4 countries.

Guy-Bernard CadièreDepartment of Digestive Surgery, Centre Hospitalier Universitaire St. Pierre, 322 rue Haute, Brussels 1000, Belgium. Guy-Bernard_CADIERE@stpierre-bru.be
Michel Buset
Vinciane Muls
Amin Rajan
Thomas Rösch
Alexander J Eckardt
Joseph Weerts
Boris Bastens
Guido Costamagna
Michele Marchese
Hubert Louis
Fazia Mana
Filip Sermon
Anna K Gawlicka
Michael A Daniel
Jacques Devière
Centre Hospitalier Universitaire de Saint-Pierre · BECharité - Universitätsmedizin Berlin · DEEndoGastric Solutions (United States) · USUniversità Cattolica del Sacro Cuore · ITUniversité Libre de Bruxelles · BECentre Hospitalier Interrégional Edith Cavell · BEUniversitair Ziekenhuis Brussel · BEVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.

methodsPatients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm.

resultsThe TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.

conclusionThe 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.

Indexed as

AdultAgedChronic DiseaseEndoscopy, GastrointestinalFemaleFundoplicationGastroesophageal RefluxHumansMaleMiddle AgedPostoperative ComplicationsProspective StudiesTreatment Outcome

Identifiers

PMID18443855
PMCPMC2490723
OpenAlexW2091471784

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.