Department of Surgery, University of Texas Southwestern, Dallas, TX; Department of Surgery, North Texas VA Health Care System, Dallas, TX.
Department of Surgery, University of Wisconsin, Madison, WI.
Surgery. 2024 Feb;175(2):258-264. doi: 10.1016/j.surg.2023.10.017. Epub 2023 Nov 30.
The purpose of this study was to (1) compare post-treatment outcomes of operative and nonoperative management of acute appendicitis in multi-morbid patients and (2) evaluate the generalizability of prior clinical trials by determining whether outcomes differ in multi-morbid patients compared to the young and healthy patients who resemble prior clinical trial participants.
We conducted a retrospective cohort study using the National Inpatient Sample from 2004 to 2017. We included 368,537 patients with acute, uncomplicated appendicitis who were classified as having 0 or 2+ comorbidities. We compared inpatient morbidity, mortality, length of stay, and costs using propensity scores. Unmeasured confounding was addressed with probabilistic sensitivity analysis.
Overall, 5% of patients without comorbidities were treated nonoperatively versus 20% of multi-morbid patients. Compared to surgery, nonoperative management was associated with a 3.5% decrease in complications (95% confidence interval 3%-4%) for multi-morbid patients, but there was no significant difference for patients without comorbidity. However, nonoperative management was associated with a 1.5% increase in mortality for multimorbid patients (95% confidence interval 1.3%-1.7%). Costs and length of stay were lower for all patients treated with surgery. Probabilistic sensitivity analysis showed that results were robust to the effects of unmeasured confounding.
Our results raise concerns about the generalizability of clinical trials that compared nonoperative and operative management of appendicitis because (1) those trials enrolled mostly young and healthy patients, and (2) results in multi-morbid patients differ from outcomes in younger and healthier patients.
本研究旨在:(1) 比较多合并症患者急性阑尾炎手术与非手术治疗的治疗后结局;(2) 通过确定多合并症患者的结局与类似既往临床试验参与者的年轻健康患者的结局是否存在差异,评估既往临床试验的普遍性。
我们使用 2004 年至 2017 年的国家住院患者样本进行了回顾性队列研究。我们纳入了 368537 例患有急性单纯性阑尾炎的患者,这些患者被分为 0 或 2+合并症。我们使用倾向评分比较了住院发病率、死亡率、住院时间和费用。使用概率敏感性分析解决未测量的混杂因素。
总体而言,5%无合并症的患者接受非手术治疗,而 20%的多合并症患者接受非手术治疗。与手术相比,非手术治疗与多合并症患者并发症减少 3.5%(95%置信区间 3%-4%)相关,但无合并症患者无显著差异。然而,非手术治疗与多合并症患者的死亡率增加 1.5%(95%置信区间 1.3%-1.7%)相关。所有接受手术治疗的患者的成本和住院时间均较低。概率敏感性分析表明,结果对未测量混杂因素的影响具有稳健性。
我们的研究结果对比较阑尾炎非手术与手术治疗的临床试验的普遍性提出了担忧,原因是:(1) 这些试验主要纳入了年轻和健康的患者;(2) 多合并症患者的结果与年轻和健康患者的结果不同。