Evidence map›Paper›PMID 22236534›Full record

Trial reportTrials2012

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): study protocol for a randomized controlled trial.

Kirsten Kortram, Bert van Ramshorst, Thomas L Bollen, Marc G H Besselink, Dirk J Gouma, Tom Karsten, Philip M Kruyt, Grard A P Nieuwenhuijzen, Johannes C Kelder, Ellen Tromp and 1 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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

48 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
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  8. Article
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  11. Review
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  15. Predictive evaluation of SIRI, SII, PNI, and GPS in cholecystostomy application in patients with acute cholecystitis.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2022
    Article
  16. Article
  17. Clinical and Survival Outcomes Using Percutaneous Cholecystostomy Tube Alone or Subsequent Interval Cholecystectomy to Treat Acute Cholecystitis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
    Article
  18. Review
  19. Article
  20. Percutaneous Cholecystostomy Versus Conservative Treatment for Acute Cholecystitis: a Cohort Study.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
    Article
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

11 authors.

Kirsten KortramDept of Surgery, St, Antonius Hospital Nieuwegein.
Bert van Ramshorst
Thomas L Bollen
Marc G H Besselink
Dirk J Gouma
Tom Karsten
Philip M Kruyt
Grard A P Nieuwenhuijzen
Johannes C Kelder
Ellen Tromp
Djamila Boerma

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLaparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. METHODS/

designThe CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. DISCUSSION: The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients.

trial registrationNetherlands Trial Register (NTR): NTR2666.

Indexed as

Cholecystectomy, LaparoscopicCholecystostomyResearch DesignCholecystitis, AcuteHospital CostsHospitals, TeachingHumansLength of StayNetherlandsRisk AssessmentRisk FactorsTime FactorsTreatment Outcome

Identifiers

PMID22236534
PMCPMC3285056

What OpenQuestion holds

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Registered trials

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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.