Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Finnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland.
JAMA Netw Open. 2024 Nov 4;7(11):e2447459. doi: 10.1001/jamanetworkopen.2024.47459.
During the past decade, spinal surgical procedures have been increasingly performed on an ambulatory basis, a change in clinical practice supported only by observational evidence thus far. There have been no randomized clinical trials (RCTs) comparing ambulatory care with inpatient care after any spinal surgery.
To assess whether ambulatory care is noninferior to overnight hospital surveillance in functional outcome, as measured by Neck Disability Index (NDI), in adults after anterior cervical decompression and fusion (ACDF) for cervical radiculopathy.
DESIGN, SETTING, AND PARTICIPANTS: This parallel group, noninferiority RCT enrolled patients at 3 tertiary neurosurgical centers in Finland (University Hospitals of Helsinki, Turku, and Oulu) between June 2019 and February 2021, with a final follow-up in October 2021. Patients aged 18 to 62 years who underwent 1-level or 2-level ACDF due to cervical radiculopathy were assessed for eligibility. After surgery, participants were randomly assigned to either ambulatory care or overnight hospital surveillance. Intention-to-treat data analyses were conducted in August 2022.
Patients randomly assigned to ambulatory care were kept under surveillance for 6 to 8 hours after surgery and then discharged. Patients assigned to overnight hospital surveillance were kept in the ward for 24 hours or longer.
The primary outcome was NDI at 6 months. A minimal important difference of 17.3 percentage points for NDI was set as the margin of noninferiority.
Among the 105 patients (mean [SD] age, 47.0 [7.9] years; 54 women [50%]) randomly assigned to ambulatory care (n = 52) or overnight hospital surveillance (n = 53), 94 (90%) completed the trial. Four (8%) patients who received ambulatory care crossed over to overnight hospital surveillance. Seventy-nine patients (75%) had a 1-level ACDF and 26 (25%) had a 2-level ACDF. At 6 months after surgery, the mean NDI was 13.3% (95% CI, 9.3%-17.3%) in the ambulatory care group and 12.2% (95% CI, 8.2%-16.2%) in the overnight hospital surveillance group (between-group mean difference, 1.1 [95% CI, -4.6 to 6.8] percentage points).
In this RCT comparing functional outcomes of ambulatory care vs overnight hospital surveillance after ACDF, ambulatory care resulted in noninferior functional outcomes.
ClinicalTrials.gov Identifier: NCT03979443.
在过去的十年中，脊柱手术已经越来越多地在门诊进行，这一临床实践的改变目前仅得到观察性证据的支持。还没有随机临床试验 (RCT) 比较过任何脊柱手术后的门诊护理和住院护理。
评估在接受前路颈椎减压融合术 (ACDF) 治疗神经根型颈椎病的成年人中，与过夜住院监测相比，门诊护理在功能结果方面（以 Neck Disability Index [NDI] 衡量）是否不劣于后者。
设计、地点和参与者：这项平行组、非劣效性 RCT 在芬兰的 3 家三级神经外科中心（赫尔辛基大学医院、图尔库大学医院和奥卢大学医院）进行，招募了 2019 年 6 月至 2021 年 2 月期间的患者，并于 2021 年 10 月进行了最终随访。评估了年龄在 18 岁至 62 岁之间、因神经根型颈椎病而行 1 级或 2 级 ACDF 的患者是否符合入选条件。手术后，参与者被随机分配到门诊护理或过夜住院监测组。在 2022 年 8 月进行了意向治疗数据分析。
被随机分配到门诊护理的患者在手术后接受 6 至 8 小时的监测，然后出院。被分配到过夜住院监测的患者则在病房中留观 24 小时或更长时间。
主要结局是 6 个月时的 NDI。将 NDI 差值 17.3 个百分点设为非劣效性边界。
在 105 名（平均[标准差]年龄，47.0[7.9]岁；54 名女性[50%]）随机分配至门诊护理（n=52）或过夜住院监测（n=53）的患者中，94 名（90%）完成了试验。4 名（8%）接受门诊护理的患者交叉至过夜住院监测。79 名患者（75%）行 1 级 ACDF，26 名患者（25%）行 2 级 ACDF。手术后 6 个月，门诊护理组的 NDI 平均为 13.3%（95% CI，9.3%-17.3%），过夜住院监测组为 12.2%（95% CI，8.2%-16.2%）（组间平均差值，1.1[95% CI，-4.6 至 6.8]个百分点）。
在这项比较 ACDF 后门诊护理与过夜住院监测的功能结果的 RCT 中，门诊护理导致了非劣效的功能结果。
ClinicalTrials.gov 标识符：NCT03979443。
