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根治性膀胱切除术后ERAS方案在现实临床实践中的结果分析(俄罗斯首个前瞻性多中心研究)

[Analysis of the results of ERAS protocol in real-life clinical practice AFTER radical cystectomy (the first prospective multicenter study in Russia)].

作者信息

Kotov S V, Khachatryan A L, Kotova D P, Guspanov R I, Bezrukov E A, Prostomolotov A O, Nosov A, Reva S A, Semeno D V, Pavlov V N, Izmailov A A, Deneyko A C

机构信息

Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.

Department of Urology named after R.M. Fronstein of FGAOU VO of I.M. Sechenov First Moscow State Medical University of Minzdrav of Russia, Moscow, Russia.

出版信息

Urologiia. 2019 Dec 31(6):60-66.

Abstract

AIM

to carry out a multicenter prospective analysis of the results of the ERAS protocol in patients undergoing radical cystectomy in real-life clinical practice. The aims of the study were to assess the complication and mortality rate after radical cystectomy using the ERAS protocol and to assess how often ERAS protocol was imple- mented.

MATERIALS AND METHODS

a multicenter study was carried out in 4 clinics in Russia. A total of 134 patients who underwent radical cystectomy in 2017 were prospectively analyzed. Open and laparoscopic radical cystectomy was performed in 35 (26.1%) and 99 (73.9%) patients, respectively. Bricker procedure prevailed as a method for urine derivation (91.7%). Complication and mortality rate, and each principle of ERAS protocol was analyzed both in the general sample of patients and separately for open and laparoscopic radical cystectomy.

RESULTS

length of hospitalization before the radical cystectomy was 1 (1-2) day. The median duration of surgery was 260 (205-300) minutes, median blood loss was 300 (200-400) ml. The median of the patients time in ICU was 1 (0-2) day. A total of 95 (70%) complications were recorded in the 90-day period after the surgery, including Clavien I-II category in 52 (38.8%) cases and Clavien III-IV in 43 (32%) cases. Of these, gastrointestinal tract complications were predominated. Gastroparesis requiring a nasogastric tube was observed in 16 (11.9%) patients. Ileus developed in 43 (32.1%) cases, and 22 patients (16.4 %) were managed conservatively; however, 21 patients (15.7%) undergone to reoperation. A 90-days mortality reached 5.2% and the main causes included multiple organ failure as a complication of peritonitis, acute heart failure after myocardial infarction and massive bleeding. Re-hospitalization rate was 9.7% (n=13). Length of stay was 12 (9-16) days. According to univariate and multivariate analysis, an absence of antibacterial prophylaxis, a history of coronary heart disease and the patients age more than 75 years were predictors of an increased complication rate. A 30-days mortality rate is 5.2%, and re-hospitalization was required in 9.7% (n=13) cases. An average length of stay was 12 (9-16) days. Frequency of implementation of ERAS protocol in each of the participating clinic varied. Open and laparoscopic radical cystectomy have insignificant differences in some intra- and postoperative parameters, but, in general, both approaches are comparable in terms of complications, mortality, and length of stay.

CONCLUSION

  1. Despite the use of the ERAS protocol, radical cystectomy has a high frequency of complications (up to 70%); most of them are Clavien I-II. A 30-days mortality rate is 5.2%, and re-hospitalization is required in 9.7% cases. 2. Univariate and multivariate analysis showed that an absence of antibacterial prophylaxis, a coronary heart disease and the patients age more than 75 years are predictors of an increased complication rate. 3. Open and laparoscopic radical cystectomy have insignificant differences in some intra- and postoperative parameters, but, in general, both approaches are comparable in terms of complications, mortality, and length of stay. 4. To obtain more convincing data on the ERAS protocol after radical cystectomy, long-term studies are required.
摘要

目的

在现实临床实践中对接受根治性膀胱切除术患者的加速康复外科(ERAS)方案结果进行多中心前瞻性分析。本研究的目的是评估采用ERAS方案进行根治性膀胱切除术后的并发症和死亡率,并评估ERAS方案的实施频率。

材料与方法

在俄罗斯的4家诊所开展了一项多中心研究。对2017年接受根治性膀胱切除术的134例患者进行了前瞻性分析。分别有35例(26.1%)和99例(73.9%)患者接受了开放性和腹腔镜根治性膀胱切除术。Bricker手术作为尿液改道方法占主导(91.7%)。对患者总体样本以及开放性和腹腔镜根治性膀胱切除术分别分析了并发症和死亡率以及ERAS方案的各项原则。

结果

根治性膀胱切除术前的住院时间为1(1 - 2)天。手术中位时长为260(205 - 300)分钟,中位失血量为300(200 - 400)ml。患者在重症监护病房(ICU)的中位时间为1(0 - 2)天。术后90天共记录到95例(70%)并发症,其中Clavien I - II级52例(38.8%),Clavien III - IV级43例(32%)。其中,胃肠道并发症占主导。16例(11.9%)患者出现需要鼻胃管的胃轻瘫。43例(32.1%)发生肠梗阻,22例(16.4%)保守治疗;然而,21例(15.7%)接受了再次手术。90天死亡率达5.2%,主要原因包括作为腹膜炎并发症的多器官功能衰竭、心肌梗死后急性心力衰竭和大出血。再住院率为9.7%(n = 13)。住院时长为12(9 - 16)天。单因素和多因素分析显示,未进行抗菌预防、有冠心病病史以及患者年龄超过75岁是并发症发生率增加的预测因素。30天死亡率为5.2%,9.7%(n = 13)的病例需要再住院。平均住院时长为12(9 - 16)天。各参与诊所中ERAS方案的实施频率各不相同。开放性和腹腔镜根治性膀胱切除术在一些术中和术后参数方面差异不显著,但总体而言,两种方法在并发症、死亡率和住院时长方面具有可比性。

结论

  1. 尽管采用了ERAS方案,根治性膀胱切除术的并发症发生率仍较高(高达70%);其中大多数为Clavien I - II级。30天死亡率为5.2%,9.7%的病例需要再住院。2. 单因素和多因素分析表明,未进行抗菌预防、冠心病以及患者年龄超过75岁是并发症发生率增加的预测因素。3. 开放性和腹腔镜根治性膀胱切除术在一些术中和术后参数方面差异不显著,但总体而言,两种方法在并发症、死亡率和住院时长方面具有可比性。4. 为获得关于根治性膀胱切除术后ERAS方案更有说服力的数据,需要进行长期研究。

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