Ambulatory Surgical Procedures, Enhanced Recovery After Surgery, Fast-track Surgery, Hip, Knee, Patient Satisfaction, Perioperative Medicine, Perioperative/Postoperative Complications
Conditions
Keywords
Hip Replacement, Knee Replacement, Perioperative Medicine, Enhanced Recovery After Surgery, Perioperative/Postoperative Complications, Ambulatory Surgical Procedures
Brief summary
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.
Detailed description
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.
Interventions
Standard surgical procedure but with planned discharge on day of surgery
Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
Sponsors
Study design
Eligibility
Inclusion criteria
* age \>18 years * non-malignant surgery * danish social security number * elective procedure
Exclusion criteria
* unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of unselected patients able to undergo day-surgery procedures | 7 days postoperatively | The fraction patients eligible for day-surgery who are discharged on day of surgery. |
| postoperative morbidity | 90 days postoperatively | postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery. |
| postoperative morbidity Clavien-Dindo | 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 | 90 days postoperatively | Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare utilisation in day-surgery | 30 days postoperatively | Registration of emergency room visits, visits to general practitioners and use of medical emergency services within 30 days after having hip or knee replacement as day-surgery procedure. |
Countries
Denmark
Contacts
Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen