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临床试验/NCT05613439
NCT05613439已完成不适用

The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications

Rigshospitalet, Denmark13 个研究点 分布在 1 个国家目标入组 45,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45,000
试验地点
13
主要终点
Fraction of unselected patients able to undergo day-surgery procedures

研究概览

简要总结

This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.

详细描述

The study registry is intended for further detailed research on postoperative morbidity, feasibility and safety of day surgery and functional outcomes after fast-track hip and knee replacement in 8 dedicated Danish arthroplasty wards across all five health care regions in Denmark. The work is a continuation of the Lundbeck Foundation Centre Database on Hip and Knee Replacement also registered in ClinicalTrials but ceased enrolling in august 2017.

The aim of the registry is to provide standardized and comprehensive information on preoperative patient characteristics and postoperative complications, patient reported outcome measures and health-care utilization in fast-track hip and knee replacement within a socialized health-care system. Each department have dedicated research personel assuring registration and follow-up supervised by a datamanager, and with database-support from the Danish health Region of Southern Denmark.

All departments have similar established fast-track protocols as standard of care, but with focus on dividing patients into day-surgery, main fast-track group and high-risk cohorts.

Preoperative data includes information on prescribed medication, Clinical Frailty Score using CFS v.1, evaluation of Pain Catastrophizing Scale as well as laboratory testing of hemoglobin, kidney function, Hb1Ac in diabetics and C-reactive protein level. On the basis of the collected preoperative data a machine-learning algorithm for identifying the "high-risk" patients is being refined and with planned induction in the database.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >18 years
  • non-malignant surgery
  • danish social security number
  • elective procedure

排除标准

  • unwilling to provide informed consent

结局指标

主要结局

Fraction of unselected patients able to undergo day-surgery procedures

时间窗: 7 days postoperatively

The fraction patients eligible for day-surgery who are discharged on day of surgery.

postoperative morbidity

时间窗: 90 days postoperatively

postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery.

postoperative morbidity Clavien-Dindo

时间窗: 90 days postoperatively

Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index.

postoperative morbidity CCI

时间窗: 90 days postoperatively

Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index

次要结局

  • Healthcare utilisation in day-surgery(30 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Joergensen

Database manager

Rigshospitalet, Denmark

研究点 (13)

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