TY - JOUR
T1 - 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
AU - Issa, Luma Mahmoud
AU - Kehlet, Henrik
AU - Madsbad, Sten
AU - Lindberg-Larsen, Martin
AU - Varnum, Claus
AU - Jakobsen, Thomas
AU - Andersen, Mikkel Rathsach
AU - Bieder, Manuel Josef
AU - Overgaard, Søren
AU - Hansen, Torben Bæk
AU - Gromov, Kirill
AU - Jørgensen, Christoffer Calov
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/4/23
Y1 - 2024/4/23
N2 - 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.
AB - 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.
KW - Humans
KW - Arthroplasty, Replacement, Hip
KW - Arthroplasty, Replacement, Knee
KW - Denmark
KW - Diabetes Mellitus
KW - Glycated Hemoglobin/analysis
KW - Hypoglycemic Agents/therapeutic use
KW - Length of Stay/statistics & numerical data
KW - Multicenter Studies as Topic
KW - Observational Studies as Topic
KW - Patient Readmission/statistics & numerical data
KW - Postoperative Complications
KW - Prospective Studies
KW - Risk Factors
KW - Orthopaedic & trauma surgery
KW - General diabetes
KW - Adult anaesthesia
U2 - 10.1136/bmjopen-2023-080232
DO - 10.1136/bmjopen-2023-080232
M3 - Protocol
C2 - 38658012
SN - 2044-6055
VL - 14
JO - BMJ open
JF - BMJ open
IS - 4
M1 - e080232
ER -