Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, Umeå, Sweden.
Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.
Acta Obstet Gynecol Scand. 2024 Nov;103(11):2221-2231. doi: 10.1111/aogs.14960. Epub 2024 Sep 2.
The evidence on complication rates after gynecological surgery is based on multiple types of studies, and the level of evidence is generally low. We aimed to validate the registration of complications in the Swedish National Quality Register of Gynecological Surgery (GynOp), by cross-linkage to multiple national registers.
A national register-based study using prospectively collected data was conducted, including women who had surgery on the uterus or adnexa for benign indications from January 1, 2017, to December 31, 2020. In Sweden, complications after gynecological surgery are registered in GynOp, and if the complication has rendered any interaction with healthcare, it is also in national health registers. The GynOp register, the National Patient Register, the Prescribed Drugs Register, and the Cause of Death Register were cross-linked. Complications in GynOp and complications according to ICD10 were analyzed, as well as the cause of death if occurring within 3 months of surgery and prescription of antibiotics ≤30 days. Comparisons between the registries were descriptive.
During the study period 32 537 surgeries were performed, of which 26 214 (80.6%) were minimally invasive. Complications were reported in GynOp for 569 women (1.7%) at surgery, 1045 (3.2%) while admitted, and 3868 (13.7%) from discharge to 3 months after surgery. In comparison, according to the Patient Register, 2254 women (6.9%) had postoperative complications within 3 months of discharge (difference of 6.8 percentage points [95% confidence interval 6.2-7.2]). Furthermore, 4117 individuals (12.7%) had a prescription of antibiotics ≤30 days which could indicate a postoperative infection. The rates of hemorrhage, wound dehiscence, and thrombosis were comparable between GynOp and the Patient Register while diagnoses not leading to contact with specialized care had higher rates in the quality register. The coverage of complications was 79.1% in GynOp and 46.1% in the Patient Register, using the total number of complications from both registers as the denominator.
A higher frequency of complications is captured in GynOp than in the National Patient Register. Patient-reported outcomes assessed by a physician are beneficial in identifying complications indicating the importance of structured pre-defined follow-up over a set period.
妇科手术术后并发症发生率的证据来源于多种类型的研究,其证据水平普遍较低。我们旨在通过与多个国家登记处的交叉链接,验证瑞典妇科手术国家质量登记处(GynOp)中并发症的登记情况。
这是一项基于前瞻性收集数据的全国性登记研究,纳入了 2017 年 1 月 1 日至 2020 年 12 月 31 日期间因良性指征行子宫或附件手术的女性。在瑞典,妇科手术后的并发症会在 GynOp 中登记,如果并发症导致与医疗保健产生任何交互,也会在国家健康登记处登记。我们对 GynOp 登记处、国家患者登记处、处方药物登记处和死因登记处进行了交叉链接。我们分析了 GynOp 中的并发症和根据 ICD10 分类的并发症,以及术后 3 个月内发生的死亡原因和术后 30 天内开具抗生素的情况。对各登记处的比较采用描述性方法。
在研究期间,共进行了 32537 例手术,其中 26214 例(80.6%)为微创手术。GynOp 在手术时报告了 569 例(1.7%)女性出现并发症,住院时报告了 1045 例(3.2%),出院后至术后 3 个月时报告了 3868 例(13.7%)。相比之下,根据患者登记处,出院后 3 个月内有 2254 例(6.9%)女性出现术后并发症(差异为 6.8 个百分点[95%置信区间 6.2-7.2])。此外,4117 例(12.7%)在术后 30 天内开具了抗生素处方,这可能表明术后感染。GynOp 与患者登记处的出血、伤口裂开和血栓形成发生率相似,而无需与专科治疗接触的诊断在质量登记处的发生率更高。GynOp 中并发症的覆盖率为 79.1%,患者登记处为 46.1%,以两个登记处报告的并发症总数作为分母。
GynOp 中记录的并发症发生率高于国家患者登记处。由医生评估的患者报告结局有助于识别表明在设定时间段内进行结构化预定义随访的重要性的并发症。