Lönnrot K, Taimela S, Toivonen P, et al. Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care. BMJ Open2019;9:e032575. doi:10.1136/bmjopen-2019-032575
Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE) : a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care
|Author:||Lönnrot, Kimmo1,2; Taimela, Simo2,3; Toivonen, Pirjo2,3;|
1Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
2Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland
3Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
4Division of Clinical neurosciences, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland
5Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kys, Finland
6Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland
7Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland
8Department of Anaesthesia, Orthopaedic Hospital Orton, Helsinki, Finland
|Online Access:||PDF Full Text (PDF, 0.4 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe202003279514
|Publish Date:|| 2020-03-27
Introduction: Although a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients’ perception of symptom relief and their ability to return to normal daily activities and work.
Methods and analysis: This is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1–3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6–8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom’s criteria), patient’s satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.
Ethics and dissemination: The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
This study was supported by the State funding for university-level health research (Helsinki University Hospitals). The funding source will have no role in the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.