[Verification of clinical applicability of the non-special perioperative administration for enhanced recovery after surgery of gastric cancer patients: a Chinese single-center observational report]

Objective: To verify clinical applicability of the non-special perioperative administration for enhanced recovery after surgery (ERAS) proposed by Japanese scholars in Chinese gastric cancer patients. Methods: The main measures of the non-special perioperative administration for ERAS are as follows: (1) discussion of multiple disciplinary team before surgery; (2) rehabilitation education for patients; (3) no routine bowel preparation before surgery; (4) placement of nasogastric tube for decompression routinely before operation and removal as early as 24 hours after surgery; (5) appropriate rehydration; (6) antibiotic prophylaxis before surgery; (7) place abdominal drainage tubes when necessary; (8) epidural patient-controlled analgesia and oral medication for postoperative pain management; (9) start low-molecular-weight heparin injection 48h after surgery and ambulation every day to prevent deep vein thrombosis; (10) postoperative dietary management and supplement with parenteral nutrition intermittently; (11) remove Foley catheter about 24 hours after surgery. A retrospective cohort study was performed, including 203 patients undergoing radical gastrectomy at Department of Gastroenterology, Tianjin Medical University Cancer Institute and Hospital from January 2017 to December 2018. Inclusion criteria were patients who were ≤75 years old without distant metastasis by preoperative examination, were diagnosed as gastric adenocarcinoma by postoperative histopathology and had complete clinicopathological and follow-up data. Patients with history of other malignancies and gastrectomy, extensive implantation of the abdominal cavity or malignant ascites by intraoperative exploration, death within 1 month after surgery, and residual gastric cancer were excluded. The perioperative management methods were chosen by patients. There were 123 patients who followed non-special perioperative administration for ERAS (non-special preparation group) and 80 patients who underwent traditional perioperative management (traditional method group). The primary outcomes (postoperative hospital stay, time to the first flatus, time to the first fluid diet, time to the first ambulatory activity, morbidity of postoperative complication, mortality, and readmission rate) and secondary outcomes (operative time, intraoperative blood loss and postoperative pain score) were compared between the two groups. Results: Compared to the traditional method group, the non-special preparation group had shorter time to the first flatus [(3.6±1.1) days vs. (4.8±1.4) days, t=3.134, P=0.003], shorter time to the first liquid diet [(2.6±0.9) days vs. (5.5±1.6) days, t=15.105, P<0.001], shorter time to the first ambulatory activity [(1.9±0.5) days vs. (4.1±1.1) days, t=8.543, P<0.001] and shorter postoperative hospital stay [(9.6±2.3) days vs. (12.9±2.3) days, t=5.020, P<0.001]. Besides, incidences of pancreatic leakage [6.5% (8/123) vs. 16.3% (13/80), χ(2)=4.964, P=0.026], lymphatic leakage [1.6% (2/123) vs. 13.8% (11/80), χ(2)=11.887, P=0.001], peritoneal effusion [2.4% (3/123) vs. 10.0% (8/80), χ(2)=4.032, P=0.045], and gastroparesis [0.8% (1/123) vs. 7.5% (6/80), χ(2)=4.657, P=0.031] in the non-special preparation group were significantly lower. The overall morbidity of postoperative complications and incidences of pulmonary infection and intestinal adhesion were not significantly different between the two groups (all P>0.05). As for the secondary outcomes, compared to the traditional method group, the non-special preparation group had less intraoperative blood loss [(80.4±24.4) ml vs. (100.5±19.4) ml, t=3.134, P=0.003] and lower postoperative pain score [postoperative day 1: (4.4±0.3) vs. (5.3±0.8), t=2.504, P=0.037],while the difference in operative time was not significant (P>0.05). Conclusion: The non-special perioperative administration for ERAS proposed by Japanese scholars is effective and safe, which has certain clinical applicability and value for Chinese patients with gastric cancer.

目的： 加速康复外科（ERAS）管理途径已被大家广为熟悉并备受关注，但因其须遵循的条目繁多、且需患者高度依从，故并未普及。日本学者提出的非特殊准备胃癌根治术后ERAS管理被认为是一种新的可选择方法，本研究对这种方法是否适用于中国临床进行验证。 方法： 非特殊准备胃癌根治术后ERAS管理主要措施为：（1）术前经多学科诊疗模式讨论；（2）对患者行康复教育；（3）不常规行术前肠道准备；（4）术前常规放置鼻胃管减压，术后最快24 h内拔除；（5）适量补液；（6）手术前预防性使用抗生素；（7）按需放置腹腔引流；（8）术后疼痛管理采用硬膜外患者自控镇痛及口服药物；（9）术后48 h开始注射低分子肝素及每日离床活动预防深静脉血栓；（10）术后饮食管理，期间辅以肠外营养；（11）术后24 h左右开始拔除导尿管。采用回顾性队列研究方法，纳入2017年1月至2018年12月期间，在天津医科大学肿瘤医院胃肠肿瘤科行胃癌根治术治疗的203例患者的临床资料。病例入选标准：年龄≤75岁、术前经检查未发现有远处转移、术后组织病理诊断确定胃腺癌以及具备完善的临床病理数据及随访材料；排除有其他恶性肿瘤病史及胃切除史、术中探查发现有腹腔广泛种植转移或恶性腹水、术后1个月内死亡以及残胃癌患者。依据患者意愿，选取围手术期管理方式。有123例患者遵从日本东京大学附属医院提出的非特殊准备ERAS方式（非特殊准备组）进行围手术期管理，80例接受传统围手术期管理（传统方法组），比较两组主要结局指标（术后住院时间和首次排粪时间、流质饮食时间、下床活动时间以及术后并发症发生率、病死率、再入院率）和次要结局指标（手术时长、术中失血量及术后疼痛评分）。 结果： 非特殊准备组与传统方法组主要结局指标相比，首次排粪时间[（3.6±1.1）d比（4.8±1.4）d，t=3.134，P=0.003]、首次流质饮食时间[（2.6±0.9）d比（5.5±1.6）d，t=15.105，P<0.001]、首次下床活动时间[（1.9±0.5）d比（4.1±1.1）d，t=8.543，P<0.001]均较早，术后住院时间[（9.6±2.3）d比（12.9±2.3）d，t=5.020，P<0.001]较短，差异均有统计学意义。此外，非特殊准备组胰漏[6.5%（8/123）比16.3%（13/80），χ(2)=4.964，P=0.026]、淋巴漏[1.6%（2/123）比13.8%（11/80），χ(2)=11.887，P=0.001]、腹腔积液[2.4%（3/123）比10.0%（8/80），χ(2)=4.032，P=0.045]和胃瘫[0.8%（1/123）比7.5%（6/80），χ(2)=4.657，P=0.031]的发生率均较低。但两组术后总体并发症发生率、肺感染以及肠粘连的发生率差异无统计学意义（均P>0.05）。次要结局指标中，非特殊准备组的术中失血量[（80.4±24.4）ml比（100.5±19.4）ml，t=3.134，P=0.003]以及术后疼痛评分[术后第1天：（4.4±0.3）分比（5.3±0.8）分，t=2.504，P=0.037]均低于传统组；但两组手术时间差异无统计学意义（P>0.05）。 结论： 非特殊准备的胃癌根治术后ERAS方案有效、安全，对于中国胃癌手术患者具有一定的临床适用性和应用价值。.

Keywords: Enhanced recovery after surgery; Retrospective Cohort study; Stomach neoplasms.