PMID- 31772100 OWN - NLM STAT- MEDLINE DCOM- 20201102 LR - 20240327 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 9 IP - 11 DP - 2019 Nov 26 TI - 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. PG - e032575 LID - 10.1136/bmjopen-2019-032575 [doi] LID - e032575 AB - 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. TRIAL REGISTRATION NUMBER: NCT03979443. CI - (c) 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. FAU - Lonnrot, Kimmo AU - Lonnrot K AUID- ORCID: 0000-0003-4361-1007 AD - Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland kimmo.lonnrot@hus.fi. AD - Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. FAU - Taimela, Simo AU - Taimela S AUID- ORCID: 0000-0001-6755-2983 AD - Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. AD - Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. FAU - Toivonen, Pirjo AU - Toivonen P AD - Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. AD - Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. FAU - Aronen, Pasi AU - Aronen P AD - Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. FAU - Koski-Palken, Anniina AU - Koski-Palken A AD - Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. FAU - Frantzen, Janek AU - Frantzen J AD - Division of Clinical neurosciences, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland. FAU - Leinonen, Ville AU - Leinonen V AD - Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kys, Finland. AD - Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland. FAU - Silvasti-Lundell, Marja AU - Silvasti-Lundell M AD - Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland. FAU - Forster, Johannes AU - Forster J AD - Department of Anaesthesia, Orthopaedic Hospital Orton, Helsinki, Finland. FAU - Jarvinen, Teppo AU - Jarvinen T AUID- ORCID: 0000-0003-3713-956X AD - Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. AD - Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. CN - FACADE investigators LA - eng SI - ClinicalTrials.gov/NCT03979443 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191126 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - *Ambulatory Care MH - Cervical Vertebrae/*surgery MH - *Decompression, Surgical/adverse effects MH - Equivalence Trials as Topic MH - Finland MH - *Hospitalization MH - Humans MH - Leisure Activities MH - Patient Satisfaction MH - Postoperative Complications MH - Prospective Studies MH - Radiculopathy/*surgery MH - Return to Work MH - Sick Leave MH - *Spinal Fusion/adverse effects MH - Time Factors MH - Treatment Outcome MH - Randomized Controlled Trials as Topic PMC - PMC6886918 OTO - NOTNLM OT - anterior cervical decompression and fusion OT - cervical spine surgery OT - outpatient care OT - protocol OT - randomised controlled trial COIS- Competing interests: None declared. FIR - Lonnrot, Kimmo IR - Lonnrot K FIR - Jarvinen, Teppo IR - Jarvinen T FIR - Taimela, Simo IR - Taimela S FIR - Silvasti-Lundell, Marja IR - Silvasti-Lundell M FIR - Forster, Johannes IR - Forster J FIR - Koski-Palken, Anniina IR - Koski-Palken A FIR - Satopaa, Jarno IR - Satopaa J FIR - Rezai-Jahromi, Behnam IR - Rezai-Jahromi B FIR - Aronen, Pasi IR - Aronen P FIR - Toivonen, Pirjo IR - Toivonen P FIR - Rautanen, Marketta IR - Rautanen M FIR - Tuomisto, Maarit IR - Tuomisto M EDAT- 2019/11/28 06:00 MHDA- 2020/11/03 06:00 PMCR- 2019/11/26 CRDT- 2019/11/28 06:00 PHST- 2019/11/28 06:00 [entrez] PHST- 2019/11/28 06:00 [pubmed] PHST- 2020/11/03 06:00 [medline] PHST- 2019/11/26 00:00 [pmc-release] AID - bmjopen-2019-032575 [pii] AID - 10.1136/bmjopen-2019-032575 [doi] PST - epublish SO - BMJ Open. 2019 Nov 26;9(11):e032575. doi: 10.1136/bmjopen-2019-032575.