Wu Zhouqiao, Shi Jinyao, Shan Fei, Li Ziyu, Ji Jiafu
Department of Gastrointestinal Cancer Center, Ward I(, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing 100142, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Feb 25;20(2):177-183.
To analyze the change in postoperative complication rate after gastric cancer surgery registered in the Peking University Cancer Hospital in recent 11 years and the learning curve of complication registration, and to investigate how to improve the complication registration and evaluation in gastric cancer surgery.
Patients who underwent open or laparoscopic gastric cancer surgery between April 14, 2005 and February 15, 2016 in our institution were included in the study, and those without essential clinical and administrative data were excluded. Data were biennially collected, and linear regression was performed to investigate the changes of the following parameters, including overall complication rate, severe complication proportion (proportion of complications with Clavien-Dindo score ≥III(a in the total registered complications), re-operation rate and the major complication rate.
A total of 5 666 patients were included in the analysis, with 4 111 males (72.56%) and 1 555 females (27.44%). The average age was (58.87±11.50) years and average BMI was(23.15±3.30) kg/m. There were 305 patients included in the 2005-2006 interval, 810 patients in 2007-2008, 957 patients in 2009-2010, 1 163 patients in 2011-2012, 1 421 patients in 2013-2014, and 1 010 patients in 2015-2016, respectively. The overall re-operation rate was 2.34%(133/5 666), postoperative mortality was 0.41%(23/5 666), registered complication rate was 19.66%(1 114/5 666), severe complication proportion was 32.28%(338/1 047), and the proportion of complication missing the Clavien-Dindo score was 6.01%(67/1 114). The linear regression showed the re-operation rate (r=0.13, P=0.801) and postoperative mortality (r=0.58, P=0.231) remained low (< 4% and < 1% respectively) since 2005, and showed no statistical significance. The registered complication rate showed evident increase from 3.93%(12/305) to 29.13%(414/1 421) between 2005 and 2014 (r=0.92, P=0.010), and slight decrease to 22.77%(230/1 010) in 2015-2016. The severe complication proportion significantly decreased from 6/9 in 2005-2006 to 22.73%(50/220) in 2015-2016 (r=0.90, P=0.014). The proportion of complication missing the Clavien-Dindo score significantly decreased from 25.00%(3/12) in 2005-2006 to 4.35%(10/230) in 2015-2016(r=0.82, P=0.044). The most common complications were infection (9.12%, 517 cases), effusions (6.26%, 355 patients), gastrointestinal motility disorder (4.45%, 252 cases), anastomotic leakage (3.19%, 181 cases) and bleeding (2.31%, 131 cases). The registered rates of these complications all increased since 2005, and the rates of leakage and effusions decreased since 2012 while the others decreased after 2014.
According to the data from our institution in the recent 11 years, a learning curve exists in our institution for complication registration in gastric cancer surgery. The administrative data appears to be more reliable than registered complication data in quality and safety evaluation during the learning period. A detailed classification with the Clavien-Dindo score aids to the use of complication data for the quality and safety measurement.
分析北京大学肿瘤医院近11年胃癌手术后并发症发生率的变化及并发症登记的学习曲线,并探讨如何改进胃癌手术并发症的登记与评估。
纳入2005年4月14日至2016年2月15日在我院接受开放或腹腔镜胃癌手术的患者,排除无基本临床及管理数据者。每两年收集一次数据,并进行线性回归分析,以研究以下参数的变化,包括总体并发症发生率、严重并发症比例(Clavien-Dindo评分≥Ⅲ(a)的并发症在总登记并发症中的比例)、再次手术率和主要并发症发生率。
共纳入5666例患者进行分析,其中男性4111例(72.56%),女性1555例(27.44%)。平均年龄为(58.87±11.50)岁,平均BMI为(23.15±3.30)kg/m²。2005 - 2006年区间纳入305例患者,2007 - 2008年810例,2009 - 2010年957例,2011 - 2012年1163例,2013 - 2014年1421例,2015 - 2016年1010例。总体再次手术率为2.34%(133/5666),术后死亡率为0.41%(23/5666),登记并发症发生率为19.66%(1114/5666),严重并发症比例为32.28%(338/1047),未记录Clavien-Dindo评分的并发症比例为6.01%(67/1114)。线性回归显示,自2005年以来,再次手术率(r = 0.13,P = 0.801)和术后死亡率(r = 0.58,P = 0.231)一直较低(分别<4%和<1%),无统计学意义。登记并发症发生率在2005年至2014年期间从3.93%(12/305)显著增加至29.13%(414/1421)(r = 0.92,P = 0.010),在2015 - 2016年略有下降至22.77%(230/1010)。严重并发症比例从2005 - 2006年的6/9显著下降至2015 - 2016年的22.73%(50/220)(r = 0.90,P = 0.014)。未记录Clavien-Dindo评分的并发症比例从2005 - 2006年的25.00%(3/12)显著下降至2015 - 2016年的4.35%(10/230)(r = 0.82,P = 0.044)。最常见的并发症为感染(9.12%,517例)、积液(6.26%,355例)、胃肠动力障碍(4.45%,252例)、吻合口漏(3.19%,181例)和出血(2.31%,131例)。这些并发症的登记发生率自2005年以来均有所增加,其中漏和积液的发生率自2012年起下降,其他并发症自2014年起下降。
根据我院近11年的数据,我院胃癌手术并发症登记存在学习曲线。在学习期间,管理数据在质量和安全性评估方面似乎比登记的并发症数据更可靠。使用Clavien-Dindo评分进行详细分类有助于将并发症数据用于质量和安全性测量。