Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Haal, Sylke, Guman, Maimoena S. S., de Brauw, L. Maurits, van Veen, Ruben N., Schouten, Ruben, Fockens, Paul, Gerdes, Victor E. A., Dijkgraaf, Marcel G. W., Voermans, Rogier P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376318/
https://www.ncbi.nlm.nih.gov/pubmed/32703246
http://dx.doi.org/10.1186/s13063-020-04605-7
_version_ 1783562020072718336
author Haal, Sylke
Guman, Maimoena S. S.
de Brauw, L. Maurits
van Veen, Ruben N.
Schouten, Ruben
Fockens, Paul
Gerdes, Victor E. A.
Dijkgraaf, Marcel G. W.
Voermans, Rogier P.
author_facet Haal, Sylke
Guman, Maimoena S. S.
de Brauw, L. Maurits
van Veen, Ruben N.
Schouten, Ruben
Fockens, Paul
Gerdes, Victor E. A.
Dijkgraaf, Marcel G. W.
Voermans, Rogier P.
author_sort Haal, Sylke
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7376318
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-73763182020-07-23 Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial) Haal, Sylke Guman, Maimoena S. S. de Brauw, L. Maurits van Veen, Ruben N. Schouten, Ruben Fockens, Paul Gerdes, Victor E. A. Dijkgraaf, Marcel G. W. Voermans, Rogier P. Trials Update 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. BioMed Central 2020-07-23 /pmc/articles/PMC7376318/ /pubmed/32703246 http://dx.doi.org/10.1186/s13063-020-04605-7 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Update
Haal, Sylke
Guman, Maimoena S. S.
de Brauw, L. Maurits
van Veen, Ruben N.
Schouten, Ruben
Fockens, Paul
Gerdes, Victor E. A.
Dijkgraaf, Marcel G. W.
Voermans, Rogier P.
Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title_full Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title_fullStr Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title_full_unstemmed Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title_short Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
title_sort ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (upgrade trial)
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376318/
https://www.ncbi.nlm.nih.gov/pubmed/32703246
http://dx.doi.org/10.1186/s13063-020-04605-7
work_keys_str_mv AT haalsylke ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT gumanmaimoenass ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT debrauwlmaurits ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT vanveenrubenn ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT schoutenruben ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT fockenspaul ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT gerdesvictorea ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT dijkgraafmarcelgw ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial
AT voermansrogierp ursodeoxycholicacidforthepreventionofsymptomaticgallstonediseaseafterbariatricsurgerystatisticalanalysisplanforarandomisedcontrolledtrialupgradetrial