Evidence map›Paper›PMID 15319712›Full record

Trial reportAnnals of surgery2004

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial.

William O Richards, Alfonso Torquati, Michael D Holzman, Leena Khaitan, Daniel Byrne, Rami Lutfi, Kenneth W Sharp

Open access · greenAbstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgery, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 190 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
190citing papers in PubMed, 12 pooled it
12.8field-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.

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

190 citing papers in PubMed, 12 syntheses or guidelines pooled it, 537 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Fundoplication in laparoscopic Heller's cardiomyotomy for achalasia.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. ACG Clinical Guidelines: Diagnosis and Management of Achalasia.The American journal of gastroenterology · 2020
    Guideline
  6. Quality of Life Following Peroral Endoscopic Myotomy for Esophageal Achalasia: A Systematic Review and Meta-Analysis.Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2020
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Guideline
  11. Pooled it
  12. Pooled it
  13. Trial
  14. Trial
  15. Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2018
    Trial
  16. Trial
  17. Trial
  18. Trial
  19. Significance of limited hiatal dissection in surgery for achalasia.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2010
    Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

William O RichardsDepartment of Surgery, Vanderbilt University, Medical School, Nashville, Tennessee 37232, USA. bill.richards@vanderbilt.edu
Alfonso Torquati
Michael D Holzman
Leena Khaitan
Daniel Byrne
Rami Lutfi
Kenneth W Sharp
Vanderbilt University · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe sought to determine the impact of the addition of Dor fundoplication on the incidence of postoperative gastroesophageal reflux (GER) after Heller myotomy. SUMMARY BACKGROUND DATA: Based only on case series, many surgeons believe that an antireflux procedure should be added to the Heller myotomy. However, no prospective randomized data support this approach. PATIENTS AND

methodsIn this prospective, randomized, double-blind, institutional review board-approved clinical trial, patients with achalasia were assigned to undergo Heller myotomy or Heller myotomy plus Dor fundoplication. Patients were studied via 24-hour pH study and manometry at 6 months postoperatively. Pathologic GER was defined as distal esophageal time acid exposure time greater than 4.2% per 24-hour period. The outcome variables were analyzed on an intention-to-treat basis.

resultsForty-three patients were enrolled. There were no differences in the baseline characteristics between study groups. Pathologic GER occurred in 10 of 21 patients (47.6%) after Heller and in 2 of 22 patients (9.1%) after Heller plus Dor (P = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GER (relative risk 0.11; 95% confidence interval 0.02-0.59; P = 0.01). Median distal esophageal acid exposure time was lower in the Heller plus Dor (0.4%; range, 0-16.7) compared with the Heller group (4.9%; range, 0.1-43.6; P = 0.001). No significant difference in surgical outcome between the 2 techniques with respect to postoperative lower-esophageal sphincter pressure or postoperative dysphagia score was observed.

conclusionsHeller Myotomy plus Dor Fundoplication was superior to Heller myotomy alone in regard to the incidence of postoperative GER.

Indexed as

FundoplicationLaparoscopyAdultAgedDigestive System Surgical ProceduresDouble-Blind MethodEsophageal AchalasiaEsophagogastric JunctionEsophagusFemaleGastroesophageal RefluxHumansHydrogen-Ion ConcentrationMaleManometryMiddle Aged

Identifiers

PMID15319712
PMCPMC1356431
OpenAlexW2032601300

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.