The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.
Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
Abstract
Background: Approximately 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. Methods: The 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. Results: The 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 registration: The Netherlands Trial Register NL5954. Registered on 21 November 2016.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The trial was done according to the previously published trial protocol and statistical analysis plan.
“The trial was done according to the previously published trial protocol and statistical analysis plan.17,18”
A prespecified sensitivity analysis of the primary endpoint in four other predefined analysis sets was done.
“A prespecified sensitivity analysis of the primary endpoint in four other predefined analysis sets, with an increasing compliance rate or earlier initiation of the study drug in each successive analysis set, was also done (see statistical analysis plan for detailed information).18”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Stokes, C. S., Gluud, L. L., Casper, M., & Lammert, F. (2014) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2013.11.031 · Cited by 118
Magouliotis, D. E., Tasiopoulou, V. S., Svokos, A. A., Svokos, K. A., Chatedaki, C., Sioka, E., & Zacharoulis, D. (2017) · Obesity Surgery · doi:10.1007/s11695-017-2924-y · Cited by 108
Flagged first, then by citations
Research works printed but not linked: 9
- Uy MC, Talingdan-Te MC, Espinosa WZ, Daez ML, Ong JP. Ursodeoxycholic acid in the prevention of gallstone formation after bariatric surgery: a meta-analysis. Obes Surg. 2008;18(12):1532–8. · DOI · Paper page
- Boerlage TCC, Haal S, Maurits de Brauw L, Acherman YIZ, Bruin S, van de Laar A, et al. Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial). BMC Gastroenterol. 2017;17(1):164. · DOI · Paper page
- Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43. · DOI · Paper page
- Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric surgery worldwide 2013. Obes Surg. 2015;25(10):1822–32. · DOI
- Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. · DOI · Paper page
- Versteegh MM, Vermeulen KM, Evers SM, de Wit GA, Prenger R, Stolk EA. Dutch tariff for the five-level version of EQ-5D. Value Health. 2016;19(4):343–52. · DOI · Paper page
- Rosenkranz GK. Analysis sets and inference in clinical trials. Ther Innov Regul Sci. 2013;47(4):455–9. · DOI
- D’Hondt M, Sergeant G, Deylgat B, Devriendt D, Van Rooy F, Vansteenkiste F. Prophylactic cholecystectomy, a mandatory step in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass? J Gastrointest Surg. 2011;15(9):1532–6. · DOI
- Coupaye M, Calabrese D, Sami O, Msika S, Ledoux S. Evaluation of incidence of cholelithiasis after bariatric surgery in subjects treated or not treated with ursodeoxycholic acid. Surg Obes Relat Dis. 2017;13(4):681–5. · DOI · Paper page
Cited by
Sorted by citations
Haal, S., Guman, M. S. S., Boerlage, T. C. C., Acherman, Y. I. Z., de Brauw, L. M., Bruin, S., de Castro, S. M. M., van Hooft, J. E., van de Laar, A. W. J. M., Moes, D. E., et al. (2021) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(21)00301-0 · Cited by 82
Self-citation
Metadata
- Authors
- Haal, S., Guman, M. S. S., de Brauw, L. M., van Veen, R. N., Schouten, R., Fockens, P., Gerdes, V. E. A., Dijkgraaf, M. G. W., & Voermans, R. P.
- ORCID
- Haal, Sylke
- Venue
- Trials
- Published
- 2020-07-23
- Volume
- 21
- Issue
- 1
- ISSN
- 1745-6215
- PMC
- PMC7376318
- Cited by
- 10
- References
- 2
- Language
- en
- Funders
- ZonMw (848015003)
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
