Evidence map›Paper›PMID 18469091›Full record

Trial reportGut2008

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial.

L Lundell, S Attwood, C Ell, R Fiocca, J-P Galmiche, J Hatlebakk, T Lind, O Junghard, LOTUS trial collaborators

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 9 pooled it
14.7field-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

51 citing papers in PubMed, 9 syntheses or guidelines pooled it, 198 citations in OpenAlex.

  1. Evaluation of ICARUS Guidelines and Recommendations Not Supported by Randomized Controlled Trials.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2023
    Pooled it
  2. Guideline
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  8. Guideline
  9. Is there a role for anything other than a Nissen's operation?Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2010
    Pooled it
  10. Trial
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  16. 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
  17. Trial
  18. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2008
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  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 6 countries.

L LundellDepartment of Surgery, Karolinska University Hospital, Huddinge, S 141 66 Stockholm, Sweden. lars.lundell@karolinska.se
S Attwood
C Ell
R Fiocca
J-P Galmiche
J Hatlebakk
T Lind
O Junghard
LOTUS trial collaborators
AstraZeneca (Sweden) · SEHaukeland University Hospital · NOHelios Dr. Horst Schmidt Kliniken Wiesbaden · DEInserm · FRKarolinska University Hospital · SENorth Tyneside General Hospital · GBUniversity of Genoa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith the introduction of laparoscopic antireflux surgery (LARS) for gastro-oesophageal reflux disease (GORD) along with the increasing efficacy of modern medical treatment, a direct comparison is warranted. The 3-year interim results of a randomised study comparing both the efficacy and safety of LARS and esomeprazole (ESO) are reported.

methodsLOTUS is an open, parallel-group multicentre, randomised and controlled trial conducted in dedicated centres in 11 European countries. LARS was completed according to a standardised protocol, comprising a total fundoplication and a crural repair. Medical treatment comprised ESO 20 mg once daily, which could be increased stepwise to 40 mg once daily and then 20 mg twice daily in the case of incomplete GORD control. The primary outcome variable was time to treatment failure (Kaplan-Meier analysis). Treatment failure was defined on the basis of symptomatic relapse requiring treatment beyond that stated in the protocol.

results554 patients were randomised, of whom 288 were allocated to LARS and 266 to ESO. The two study arms were well matched. The proportions of patients who remained in remission after 3 years were similar for the two therapies: 90% of surgical patients compared with 93% medically treated for the intention to treat population, p = 0.25 (90% vs 95% per protocol). No major unexpected postoperative complications were experienced and ESO was well tolerated. However, postfundoplication complaints remain a problem after LARS.

conclusionsOver the first 3 years of this long-term study, both laparoscopic total fundoplication and continuous ESO treatment were similarly effective and well-tolerated therapeutic strategies for providing effective control of GORD.

Indexed as

AdultAnti-Ulcer AgentsChronic DiseaseEsomeprazoleFemaleFundoplicationGastroesophageal RefluxHumansLaparoscopyMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeAnti-Ulcer AgentsEsomeprazole

Identifiers

PMID18469091
PMCPMC2565581
OpenAlexW2101696161

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.