City of Hope National Cancer Center, Duarte, CA 90017, USA.
Eur Urol. 2012 Nov;62(5):806-13. doi: 10.1016/j.eururo.2012.06.007. Epub 2012 Jun 13.
Comprehensive and standardized reporting of adverse events after robot-assisted radical cystectomy (RARC) and urinary diversion for bladder cancer is necessary to evaluate the magnitude of morbidity for this complex operation.
To accurately identify and assess postoperative morbidity after RARC using a standardized reporting system.
DESIGN, SETTING, AND PARTICIPANTS: A total of 241 consecutive patients underwent RARC, extended pelvic lymph node dissection, and urinary diversion between 2003 and 2011. In all, 196 patients consented to a prospective database, and they are the subject of this report. Continent diversions were performed in 68% of cases.
All complications within 90 d of surgery were defined and categorized by a five-grade and 10-domain modification of the Clavien system. Univariable and multivariable logistic regression analyses were used to identify predictors of complications. Grade 1-2 complications were categorized as minor, and grade 3-5 complications were categorized as major. All blood transfusions were recorded as grade ≥2.
Eighty percent of patients (156 of 196 patients) experienced a complication of any grade ≤90 d after surgery. A total of 475 adverse events (113 major) were recorded, with 365 adverse events (77%) occurring ≤30 d after surgery. Sixty-eight patients (35%) experienced a major complication within the first 90 d. Other than blood transfusions given (86 patients [43.9%]), infectious, gastrointestinal, and procedural complications were the most common, at 16.2%, 14.1%, and 10.3%, respectively. Age, comorbidity, preoperative hematocrit, estimated blood loss, and length of surgery were predictive of a complication of any grade, while comorbidity, preoperative hematocrit, and orthotopic diversion were predictive of major complications. The 90-d mortality rate was 4.1%. The main limitation is lack of a control group.
Analysis of postoperative morbidity following RARC demonstrates a considerable complication rate, though the rate is comparable to contemporary open series that followed similar reporting guidelines. This finding reinforces the need for complete and standardized reporting when evaluating surgical techniques and comparing published series.
为了评估这种复杂手术的发病率,有必要对机器人辅助根治性膀胱切除术(RARC)和膀胱癌尿流改道术后的不良事件进行全面、标准化的报告。
使用标准化报告系统准确识别和评估 RARC 术后的发病率。
设计、设置和参与者:共有 241 例患者在 2003 年至 2011 年间接受了 RARC、扩大盆腔淋巴结清扫术和尿流改道。共有 196 例患者同意参与前瞻性数据库,他们是本报告的研究对象。68%的患者采用了控尿型尿流改道术。
术后 90d 内的所有并发症均通过 Clavien 系统的五级十域改良版进行定义和分类。采用单变量和多变量逻辑回归分析来确定并发症的预测因素。1-2 级并发症归为轻度,3-5 级并发症归为重度。所有输血均记录为≥2 级。
80%(196 例患者中有 156 例)的患者在术后 90d 内发生了任何等级≤90d 的并发症。共记录了 475 例不良事件(113 例为重大不良事件),其中 365 例不良事件(77%)发生在术后 30d 内。68 例(35%)患者在术后 90d 内发生了重大并发症。除输血(86 例[43.9%])外,感染、胃肠道和手术相关并发症最为常见,分别占 16.2%、14.1%和 10.3%。年龄、合并症、术前红细胞比容、估计失血量和手术时间是任何等级并发症的预测因素,而合并症、术前红细胞比容和原位尿流改道是重大并发症的预测因素。90d 死亡率为 4.1%。主要局限性在于缺乏对照组。
对 RARC 术后发病率的分析显示,并发症发生率相当高,但与遵循类似报告指南的当代开放系列相比,该发生率相当。这一发现强调了在评估手术技术和比较已发表的系列时,需要进行全面和标准化的报告。