Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study
Introduction During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery...
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| Format: | Article |
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e060354.full |
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| author | Markus W Hollmann Gert Jan Scheffer Wolfgang Buhre Sander van Kuijk Seppe Koopman Dianne de Korte-de Boer Peter G Noordzij Alice C Werger Jennifer Breel Carolien S E Bulte Bas A in ‘t Veld Carin G C L Wensing |
| author_facet | Markus W Hollmann Gert Jan Scheffer Wolfgang Buhre Sander van Kuijk Seppe Koopman Dianne de Korte-de Boer Peter G Noordzij Alice C Werger Jennifer Breel Carolien S E Bulte Bas A in ‘t Veld Carin G C L Wensing |
| author_sort | Markus W Hollmann |
| collection | DOAJ |
| description | Introduction During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery. The control group of the Routine Postsurgical Anesthesia Visit to Improve Patient Outcome (TRACE I) study, conducted between 2016 and 2019, will serve as a control cohort.Methods and analysis TRACE II is an observational, multicentre, prospective cohort study among surgical patients with postponed surgery due to COVID-19 in academic and non-academic hospitals in the Netherlands. We aim to include 2500 adult patients. The primary outcome will be the 30-day incidence of major postoperative complications. Secondary outcome measures include the 30-day incidence of minor postoperative complications, 1 year mortality, length of stay (in hospital, medium care and intensive care), quality of recovery 30 days after surgery and postoperative quality of life up to 1 year following surgery. Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome.Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals, with a preference for open access journals. Data will be made publicly available after publication of the main results.Trial registration number NL8841. |
| format | Article |
| id | doaj-art-82c3dcedd6bc496e8a88cb5a61046268 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-82c3dcedd6bc496e8a88cb5a610462682025-02-01T11:15:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-060354Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational studyMarkus W Hollmann0Gert Jan Scheffer1Wolfgang Buhre2Sander van Kuijk3Seppe Koopman4Dianne de Korte-de Boer5Peter G Noordzij6Alice C Werger7Jennifer Breel8Carolien S E Bulte9Bas A in ‘t Veld10Carin G C L Wensing113 Quality of Care, Amsterdam Public Health Research Institute, Amsterdam, The NetherlandsRadboudumc, Nijmegen, Gelderland, The NetherlandsDepartment of Anaesthesiology and Pain Medicine, Maastricht University Medical Centre+, Maastricht, The NetherlandsClinical Epidemiology and Medical Technology Assessment, Maastricht Universitair Medisch Centrum+, Maastricht, The NetherlandsDepartment of Anaesthesiology, Maasstad Ziekenhuis, Rotterdam, The NetherlandsDepartment of Anaesthesiology and Pain Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands1 Department of Anaesthesiology, Intensive Care and Pain management, St. Antonius Hospital, Nieuwegein, NetherlandsDepartment of Anaesthesiology and Pain Medicine, Haaglanden Medical Centre, Den Haag, The NetherlandsDepartment of Anaesthesiology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Anaesthesiology, Amsterdam UMC, Location Vrije Universiteit, Amsterdam, The NetherlandsDepartment of Anaesthesiology and Pain Medicine, Haaglanden Medical Centre, Den Haag, The NetherlandsDepartment of Anaesthesiology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The NetherlandsIntroduction During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery. The control group of the Routine Postsurgical Anesthesia Visit to Improve Patient Outcome (TRACE I) study, conducted between 2016 and 2019, will serve as a control cohort.Methods and analysis TRACE II is an observational, multicentre, prospective cohort study among surgical patients with postponed surgery due to COVID-19 in academic and non-academic hospitals in the Netherlands. We aim to include 2500 adult patients. The primary outcome will be the 30-day incidence of major postoperative complications. Secondary outcome measures include the 30-day incidence of minor postoperative complications, 1 year mortality, length of stay (in hospital, medium care and intensive care), quality of recovery 30 days after surgery and postoperative quality of life up to 1 year following surgery. Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome.Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals, with a preference for open access journals. Data will be made publicly available after publication of the main results.Trial registration number NL8841.https://bmjopen.bmj.com/content/12/6/e060354.full |
| spellingShingle | Markus W Hollmann Gert Jan Scheffer Wolfgang Buhre Sander van Kuijk Seppe Koopman Dianne de Korte-de Boer Peter G Noordzij Alice C Werger Jennifer Breel Carolien S E Bulte Bas A in ‘t Veld Carin G C L Wensing Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study BMJ Open |
| title | Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study |
| title_full | Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study |
| title_fullStr | Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study |
| title_full_unstemmed | Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study |
| title_short | Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study |
| title_sort | outcome in patients undergoing postponed elective surgery during the covid 19 pandemic trace ii study protocol for a multicentre prospective observational study |
| url | https://bmjopen.bmj.com/content/12/6/e060354.full |
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