Department of Urology and Urosurgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.
J Endourol. 2021 Apr;35(4):490-496. doi: 10.1089/end.2020.0825. Epub 2021 Jan 25.
To evaluate the Comprehensive Complication Index (CCI) for reporting complications in lower urinary tract transurethral procedures and compare it with the Clavien-Dindo classification (CDC). A total of 450 consecutive patients were included into the analyses [150 each of transurethral resection of bladder tumors (TURBT), transurethral resection of the prostate (TURP), and transurethral enucleation of the prostate using Tm:YAG, (ThuLEP)]. Complications were assessed according to the modified CDC. The CCI was calculated using a freely accessible online tool. Descriptive statistics and correlation analyses were applied to quantify operational differences and length of stay (LOS) between CDC and CCI. Sample size calculations for hypothetical clinical trials were contrasted for CDC and CCI application. Overall = 150 patients with complications (33.3%) within the first 60 days after operation were identified. Of these, = 125 (83.4%) were minor complications up to CDC grade IIIa. Of patients with complications, = 57 patients (12.6%) experienced more than one complication. Here, the cumulative CCI led to an upgrade of at least one CDC grade in 33 patients. Hence, in 22.0% of cases, the highest CDC grade underestimated the degree of complications. CCI showed higher correlation with LOS compared with CDC (all > 0.2, all -values ≤0.0001). Using CCI instead of CDC for sample calculation resulted in a strong reduction of the required number of patients for all three interventions (percentage of patient number decrease: -93.2% for TURBT, -71.8% for TURP, and -81.1% for ThuLEP). The CCI gives a more precise interpretation of the postinterventional complications of TURBT, TURP, and ThuLEP. CCI application may reduce the required sample size for clinical trials and will relieve their recruitment in the future.
评估综合并发症指数(CCI)用于报告下尿路经尿道手术中的并发症,并将其与Clavien-Dindo 分类(CDC)进行比较。共纳入 450 例连续患者进行分析[经尿道膀胱肿瘤切除术(TURBT)、经尿道前列腺切除术(TURP)和经尿道钬激光前列腺剜除术(ThuLEP)各 150 例]。根据改良的 CDC 评估并发症。使用免费的在线工具计算 CCI。应用描述性统计和相关性分析来量化 CDC 和 CCI 之间的操作差异和住院时间(LOS)。对比了假设临床试验中 CDC 和 CCI 应用的样本量计算。术后 60 天内共发现 150 例(33.3%)有并发症的患者。其中,125 例(83.4%)为 CDC 分级 IIIa 及以下的轻度并发症。有并发症的患者中,57 例(12.6%)有超过一种并发症。在此,至少有 1 种 CDC 分级的累积 CCI 导致升级的患者有 33 例。因此,在 22.0%的病例中,最高 CDC 分级低估了并发症的程度。CCI 与 LOS 的相关性高于 CDC(所有 r 值>0.2,所有 P 值≤0.0001)。用 CCI 代替 CDC 进行样本计算,三种干预措施所需的患者数量均大幅减少(患者数量减少百分比:TURBT 减少 93.2%,TURP 减少 71.8%,ThuLEP 减少 81.1%)。CCI 对 TURBT、TURP 和 ThuLEP 术后并发症的解释更为准确。CCI 的应用可能会减少临床试验所需的样本量,并减轻未来的招募负担。