Issa Luma Mahmoud, Kehlet Henrik, Madsbad Sten, Lindberg-Larsen Martin, Varnum Claus, Jakobsen Thomas, Andersen Mikkel Rathsach, Bieder Manuel Josef, Overgaard Søren, Hansen Torben Bæk, Gromov Kirill, Jørgensen Christoffer Calov
Anæstesiologisk afd, Hvidovre Hospital, Hvidovre, Denmark
Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.
BMJ Open. 2024 Apr 23;14(4):e080232. doi: 10.1136/bmjopen-2023-080232.
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.
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.
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.
NCT05613439.
围手术期血糖控制至关重要。然而，由于新型降糖药物种类繁多、特定手术的数据有限以及缺乏来自已实施的快速康复方案的数据（而快速康复方案已知可降低发病率和血糖稳态紊乱），围手术期糖尿病管理指南的复杂性增加。因此，糖尿病患者术后的结局以及围手术期糖尿病管理对术后恢复的影响仍知之甚少。
一项前瞻性观察性多中心研究，涉及丹麦的8个关节置换中心，这些中心均有记录在案的已实施快速康复方案（中位住院时间为1天）。我们将收集详细的围手术期数据，包括2022年9月至2025年12月期间1400例未经选择的连续接受髋膝关节置换术的糖尿病患者的术前糖化血红蛋白和抗糖尿病治疗情况，患者均在签署知情同意书后入组。随访期为术后90天。主要结局是快速康复全髋关节置换术（THA）、全膝关节置换术（TKA）和单髁膝关节置换术（UKA）后住院时间>4天的糖尿病患者比例以及90天再入院率。次要结局是在快速康复方案下，THA/TKA/UKA术后糖尿病患者围手术期糖尿病治疗与住院时间>2天、90天再入院率、其他患者人口统计学特征以及综合并发症指数之间的关联。
本研究将遵循《赫尔辛基宣言》和ICH - 良好临床实践指南的原则。由于这是一项关于当前实践的非干预性观察性研究，无需伦理批准。该试验已在丹麦南部地区和ClinicalTrials.gov注册。本试验的主要结果和所有子研究将发表在同行评审的国际医学期刊上。
NCT05613439。
