Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty
Introduction Perioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which...
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BMJ Publishing Group
2024-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/4/e080232.full |
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| author | Sten Madsbad Søren Overgaard Torben Bæk Hansen Claus Varnum Henrik Kehlet Martin Lindberg-Larsen Manuel Josef Bieder Kirill Gromov Thomas Jakobsen Luma Mahmoud Issa Mikkel Rathsach Andersen Christoffer Calov Jørgensen |
| author_facet | Sten Madsbad Søren Overgaard Torben Bæk Hansen Claus Varnum Henrik Kehlet Martin Lindberg-Larsen Manuel Josef Bieder Kirill Gromov Thomas Jakobsen Luma Mahmoud Issa Mikkel Rathsach Andersen Christoffer Calov Jørgensen |
| author_sort | Sten Madsbad |
| collection | DOAJ |
| description | Introduction Perioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which otherwise are known to reduce morbidity and glucose homeostasis disturbances. Consequently, outcome in patients with diabetes mellitus (DM) after surgery and the influence of perioperative diabetes management on postoperative recovery remains poorly understood.Methods and analysis A prospective observational multicentre study involving 8 arthroplasty centres across Denmark with a documented implemented fast-track programme (median length of hospitalisation (LOS) 1 day). We will collect detailed perioperative data including preoperative haemoglobin A1c and antidiabetic treatment in 1400 unselected consecutive patients with DM undergoing hip and knee arthroplasty from September 2022 to December 2025, enrolled after consent. Follow-up duration is 90 days after surgery. The primary outcome is the proportion of patients with DM with LOS >4 days and 90-day readmission rate after fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The secondary outcome is the association between perioperative diabetes treatment and LOS >2 days, 90-day readmission rate, other patient demographics and Comprehensive Complication Index for patients with DM after THA/TKA/UKA in a fast-track regimen.Ethics and dissemination The study will follow the principles of the Declaration of Helsinki and ICH-Good Clinical Practice guideline. Ethical approval was not necessary as this is a non-interventional observational study on current practice. The trial is registered in the Region of Southern Denmark and on ClinicalTrials.gov. The main results and all substudies of this trial will be published in peer-reviewed international medical journals.Trial registration number NCT05613439. |
| format | Article |
| id | doaj-art-53b4ec4bd2e94c258ae73c480e316b00 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-53b4ec4bd2e94c258ae73c480e316b002025-08-20T02:11:09ZengBMJ Publishing GroupBMJ Open2044-60552024-04-0114410.1136/bmjopen-2023-080232Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplastySten Madsbad0Søren Overgaard1Torben Bæk Hansen2Claus Varnum3Henrik Kehlet4Martin Lindberg-Larsen5Manuel Josef Bieder6Kirill Gromov7Thomas Jakobsen8Luma Mahmoud Issa9Mikkel Rathsach Andersen10Christoffer Calov Jørgensen119 Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, Copenhagen University, Copenhagen, DenmarkUniversity Clinic for Hand, Hip and Knee Surgery, Hospital Unit West Jutland, Aarhus Universitetshospital, Herning, DenmarkDepartment of Orthopaedic Surgery, Lillebaelt Hospital—University Hospital of Southern Denmark, Vejle, Denmark20 Department of Clinical Medicine, Rigshosp, Copenhagen, DenmarkOrthopaedic Surgery and Traumatology, University of Southern Denmark, Odense, DenmarkDepartment of Orthopaedic Surgery, Næstved Sygehus Ortopædkirurgi, Nastved, DenmarkHvidovre Hospital Department of Orthopaedic Surgery, Hvidovre, DenmarkDepartment of Orthopaedic Surgery, Aalborg University Hospital, Aalborg, DenmarkAnæstesiologisk afd, Hvidovre Hospital, Hvidovre, DenmarkDepartment for Orthopaedic Surgery, Gentofte University Hospital, Hellerup, DenmarkDept. of Anesthesia, Nordsjaellands Hospital, Hillerod, DenmarkIntroduction Perioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which otherwise are known to reduce morbidity and glucose homeostasis disturbances. Consequently, outcome in patients with diabetes mellitus (DM) after surgery and the influence of perioperative diabetes management on postoperative recovery remains poorly understood.Methods and analysis A prospective observational multicentre study involving 8 arthroplasty centres across Denmark with a documented implemented fast-track programme (median length of hospitalisation (LOS) 1 day). We will collect detailed perioperative data including preoperative haemoglobin A1c and antidiabetic treatment in 1400 unselected consecutive patients with DM undergoing hip and knee arthroplasty from September 2022 to December 2025, enrolled after consent. Follow-up duration is 90 days after surgery. The primary outcome is the proportion of patients with DM with LOS >4 days and 90-day readmission rate after fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The secondary outcome is the association between perioperative diabetes treatment and LOS >2 days, 90-day readmission rate, other patient demographics and Comprehensive Complication Index for patients with DM after THA/TKA/UKA in a fast-track regimen.Ethics and dissemination The study will follow the principles of the Declaration of Helsinki and ICH-Good Clinical Practice guideline. Ethical approval was not necessary as this is a non-interventional observational study on current practice. The trial is registered in the Region of Southern Denmark and on ClinicalTrials.gov. The main results and all substudies of this trial will be published in peer-reviewed international medical journals.Trial registration number NCT05613439.https://bmjopen.bmj.com/content/14/4/e080232.full |
| spellingShingle | Sten Madsbad Søren Overgaard Torben Bæk Hansen Claus Varnum Henrik Kehlet Martin Lindberg-Larsen Manuel Josef Bieder Kirill Gromov Thomas Jakobsen Luma Mahmoud Issa Mikkel Rathsach Andersen Christoffer Calov Jørgensen Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty BMJ Open |
| title | Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty |
| title_full | Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty |
| title_fullStr | Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty |
| title_full_unstemmed | Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty |
| title_short | Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty |
| title_sort | protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast track joint arthroplasty |
| url | https://bmjopen.bmj.com/content/14/4/e080232.full |
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