Evidence map›Paper›PMID 32703246›Full record

Trial reportTrials2020

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial).

Sylke Haal, Maimoena S S Guman, L Maurits de Brauw, Ruben N van Veen, Ruben Schouten, Paul Fockens, Victor E A Gerdes, Marcel G W Dijkgraaf, Rogier P Voermans

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. The Ambiguous Correlation ofMicroorganisms · 2024
    Review
  5. Management of biliary stones in bariatric surgery.Therapeutic advances in gastrointestinal endoscopy
    Review
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

9 authors at 4 institutions in 1 country.

Sylke HaalDepartment of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. s.haal@amsterdamumc.nl.ORCID http://orcid.org/0000-0001-7668-9164
Maimoena S S GumanDepartment of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.
L Maurits de BrauwDepartment of Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.
Ruben N van VeenDepartment of Surgery, OLVG, Amsterdam, the Netherlands.
Ruben SchoutenDepartment of Surgery, Flevoziekenhuis, Almere, the Netherlands.
Paul FockensDepartment of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Victor E A GerdesDepartment of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.
Marcel G W DijkgraafDepartment of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Rogier P VoermansDepartment of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Spaarne Ziekenhuis · NLAmsterdam University Medical Centers · NLFlevoziekenhuis · NLOLVG · NL

Funding

ZonMw 848015003
6 · The paper itself

Abstract

backgroundApproximately 8-15% of patients undergoing bariatric surgery develop symptomatic gallstone disease within 24 months after surgery. Ursodeoxycholic acid (UDCA) seems to effectively prevent the formation of gallstones detectable by ultrasound after bariatric surgery. The aim of the UPGRADE trial is to provide evidence on the prophylactic use of UDCA in preventing symptomatic gallstone disease postoperatively.

methodsThe UPGRADE trial is designed as a randomised, placebo-controlled, double-blind multicentre trial in patients with morbid obesity undergoing Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Patients are randomly assigned to either UDCA 900 mg daily for 6 months or placebo treatment. This paper details the statistical analysis plan (SAP) of this trial and was submitted before outcome data were available.

resultsThe primary endpoint of this trial is symptomatic gallstone disease within 24 months after bariatric surgery, defined as admission or hospital visit for symptomatic gallstone disease. Secondary outcomes consist of the development of gallstones/sludge on ultrasound at 24 months in the gallstone-negative group at baseline, presence of gallstones/sludge on ultrasound at 24 months, number of cholecystectomies, side effects of UDCA, therapy compliance, quality of life, costs and revenues. Analyses will be completed according to this pre-specified SAP. The main analysis will be performed as a standard ITT analysis using the chi-squared test. DISCUSSION: The UPGRADE trial will show if prophylactic use of UDCA reduces the incidence of symptomatic gallstone disease after bariatric surgery. Unforeseen deviations from the SAP at the time of analysis will be motivated and discussed.

trial registrationThe Netherlands Trial Register NL5954 . Registered on 21 November 2016.

Indexed as

Bariatric SurgeryObesity, MorbidCholelithiasisGastrectomyGastric BypassHumansNetherlandsQuality of LifeUrsodeoxycholic AcidUrsodeoxycholic AcidBariatric surgeryRandomised controlled trialStatistical analysis planSymptomatic gallstone diseaseUrsodeoxycholic acid

Identifiers

PMID32703246
PMCPMC7376318
OpenAlexW3045232978

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LicenceCC BY
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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.