Rai Pragya, Johnston Stephen S, Chaudhuri Rusha, Naoumtchik Elena, Pollack Esther
Epidemiology Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA.
Decision Science, MuSigma, Bengaluru, Karnataka, India.
Med Devices (Auckl). 2021 Mar 31;14:87-95. doi: 10.2147/MDER.S298975. eCollection 2021.
The ability of curved cutter staplers (CCS) to conform to the complex anatomy of the rectum has led to their widespread use in open low anterior resection (LAR). We describe the incidence of complications and their association with healthcare utilization and hospital-borne costs among patients who underwent open LAR with CCS, with the intent to provide contextual epidemiologic and economic burden data for future evaluations of innovations that may lead to a reduced incidence of complications.
Retrospective cohort study using Premier Healthcare Database. Studied patients were ≥18 years who underwent inpatient open LAR with CCS between October 1, 2016 and March 30, 2020 (index admission). Complications of interest included anastomotic leak, bleeding, infection, transfusion, and device complications/adverse incidents during the index admission. Outcomes included index admission hospital length of stay (LOS), non-home discharge status, total operating room (OR) time, total hospital-borne costs, and all-cause readmissions within 30, 60, and 90 days post discharge from index admission. Multivariable regression models were used to compare outcomes between patients with vs without any complication of interest.
The study included 618 patients with a mean age of 61 years, of whom 57% were males. The incidence proportion of any complication during the index admission for open LAR with CCS was 28% (95% CI: [23.9%, 31.0%], n=170). As compared with patients experiencing no complications, those with a complication had higher adjusted mean total hospital costs ($38,159 vs $22,303, p<0.001), non-home discharge status (21.8% vs 9.2%, p=0.004), mean LOS (13 days vs 6 days, p<0.001), and mean OR time (362 mins vs 291 mins, p<0.001). There were no significant differences in all-cause readmissions between patients with vs without complications.
Among patients undergoing open LAR with CCS, over a quarter of patients experienced a complication, resulting in a substantial burden to the healthcare system.
弧形切割吻合器(CCS)能够适应直肠的复杂解剖结构,这使得其在开放性低位前切除术(LAR)中得到广泛应用。我们描述了接受CCS开放性LAR手术患者的并发症发生率及其与医疗利用和医院成本的关联,旨在为未来评估可能降低并发症发生率的创新技术提供背景流行病学和经济负担数据。
使用Premier医疗数据库进行回顾性队列研究。研究对象为2016年10月1日至2020年3月30日期间(索引入院)接受住院开放性LAR手术且年龄≥18岁的患者。感兴趣的并发症包括索引入院期间的吻合口漏、出血、感染、输血以及器械并发症/不良事件。结局指标包括索引入院的住院时间(LOS)、非回家出院状态、总手术室(OR)时间、总医院成本以及索引入院出院后30、60和90天内的全因再入院情况。使用多变量回归模型比较有或无任何感兴趣并发症的患者之间的结局。
该研究纳入了618例平均年龄为61岁的患者,其中57%为男性。接受CCS开放性LAR手术的患者在索引入院期间发生任何并发症的发生率为28%(95%CI:[23.9%,31.0%],n = 170)。与未发生并发症的患者相比,发生并发症的患者调整后的平均总医院成本更高(38,159美元对22,303美元,p < 0.001),非回家出院状态更高(21.8%对9.2%,p = 0.004),平均LOS更长(13天对6天,p < 0.001),平均OR时间更长(362分钟对291分钟,p < 0.001)。有或无并发症的患者在全因再入院方面无显著差异。
在接受CCS开放性LAR手术的患者中,超过四分之一的患者发生了并发症,给医疗系统带来了沉重负担。