Clavien-Dindo分级在达芬奇机器人手术系统和腹腔镜辅助全胃D2根治术后近期并发症评估中的应用价值

Application value of Clavien-Dindo classification in evaluation of postoperative short-term complications of Da Vinci robotic-assisted or laparoscopic-assisted total gastrectomy with D2 lymphadenectomy

  • 摘要: 目的:探讨Clavien-Dindo分级在达芬奇机器人手术系统和腹腔镜辅助全胃D2根治术后近期并发症评估中的应用价值。
    方法:采用回顾性队列研究方法。收集2016年1月至2019年1月中国人民解放军联勤保障部队第九四○医院收治的262例胃癌患者的临床病理资料;男214例,女48例;年龄为 (58±11)岁,年龄范围为17~81岁。262例患者中,120例行达芬奇机器人手术系统辅助全胃切除+D2淋巴结清扫+Roux-en-Y吻合术,设为机器人组;142例行腹腔镜辅助全胃切除+D2淋巴结清扫+Roux-en-Y吻合术,设为腹腔镜组。观察指标:(1)术中及术后情况。(2)术后病理学情况。(3)并发症情况。(4)分层分析。(5)随访情况。采用门诊和电话方式进行随访,了解患者术后2个月内并发症情况,肿瘤复发情况和生存情况。随访时间截至2019年5月。正态分布的计量资料以±s表示,组间比较采用t检验。偏态分布的计量资料以M(范围)表示,组间比较采用Mann-Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用x2检验或Fisher确切概率法。等级资料组间比较采用秩和检验。
    结果:(1)术中及术后情况:机器人组患者中转开腹、手术时间、术中出血量、淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间、术后住院时间分别为1例、(243±42)min、100 mL(100~150 mL)、(38±15)枚、(2.8±1.0)d、3 d(3~4 d)、11 d(9~13 d);腹腔镜组患者上述指标分别为2例、(244±38)min、100 mL(100~150 mL)、 (34±14)枚、(3.2±1.0)d、4 d(3~5 d)、10 d(9~13 d),两组患者淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间比较,差异均有统计学意义(t=2.068,-3.030,Z=-3.370,P<0.05);两组患者中转开腹、手术时间、术中出血量、术后住院时间比较,差异均无统计学意义(x2=0.000,t=-0.158,Z= -1.824,-0.088,P>0.05)。(2)术后病理学情况:机器人组患者高分化、中分化、低分化、印戒细胞癌及其他类型,pT分期T1b期、T2期、T3期、T4a期,pN分期N0期、N1期、N2期、N3a期、N3b期,pTNM分期ⅠB期、ⅡA期、ⅡB期、ⅢA期、ⅢB期、ⅢC期分别为6、50、55、9例,10、22、63、25例,42、19、19、24、16例,17、22、23、20、23、15例;腹腔镜组患者上述指标分别为4、42、84、12例,6、18、81、37例,39、27、32、19、25例,13、19、28、39、16、27例,两组患者上述指标比较,差异均无统计学意义(Z=-1.880,-1.827,-0.140,-1.460,P>0.05)。(3)并发症情况:机器人组患者发生Ⅰ级并发症、Ⅱ级并发症、Ⅲa级并发症、Ⅲb级并发症、Ⅳa级并发症、Ⅳb级并发症、死亡、总体并发症、严重并发症的例数分别为9、6、3、2、2、0、0、22、7例;腹腔镜组患者上述指标分别为12、15、9、6、3、1、1、47、20例,两组患者发生总体并发症、严重并发症比较,差异均有统计学意义(x2=7.309,4.790,P<0.05),两组患者发生Ⅰ级并发症、Ⅱ级并发症、Ⅲa级并发症、Ⅲb级并发症、Ⅳa级并发症、Ⅳb级并发症、死亡比较,差异均无统计学意义(x2=0.080,2.730,1.042,0.704,0.000,0.000,0.000,P>0.05)。(4)分层分析:机器人组患者男性、女性、年龄≥65岁、年龄<65岁、体质量指数(BMI)≥24 kg/m2、BMI<24 kg/m2、肿瘤直径≥5 cm、肿瘤直径<5 cm、有腹部手术史、无腹部手术史、肿瘤位于胃上部、肿瘤位于胃中部、美国麻醉医师协会(ASA)分级Ⅰ~Ⅱ级、ASA分级Ⅲ级,病理学分化程度良好、病理学分化程度较差,pTNM分期Ⅰ~Ⅱ期、pTNM分期Ⅲ期,手术时间≥250 min、手术时间<250 min,术中出血量≥150 mL、术中出血量<150 mL、淋巴结清扫数目≥25枚、淋巴结清扫数目<25枚患者发生总体并发症例数分别为15、7、14、8、11、11、16、6、4、18、19、3、15、7、7、15、8、14、12、10、12、10、14、8例;腹腔镜组患者上述指标分别为33、14、17、30、16、31、36、11、11、36、27、20、31、16、13、34、14、33、24、23例,两组男性、年龄≥ 65岁、年龄<65岁、BMI<24 kg/m2、肿瘤直径≥5 cm、无腹部手术史、肿瘤位于胃中部、ASA分级Ⅰ~Ⅱ级、ASA分级Ⅲ级、病理学分化程度良好、pTNM 分期Ⅲ期、手术时间≥250 min、术中出血量<150 mL、淋巴结清扫数目≥25枚患者发生总体并发症比较,差异均有统计学意义(x2=6.683,4.207,6.761,7.438,4.297,6.325,9.433,3.970,4.850,4.911,3.952,3.915,6.865,4.128,P<0.05);两组女性、BMI≥24 kg/m2、肿瘤直径<5 cm、有腹部手术史、肿瘤位于胃上部、病理学分化程度较差、pTNM分期Ⅰ~Ⅱ期、手术时间<250 min、术中出血量≥150 mL、淋巴结清扫数目<25枚患者发生总体并发症比较,差异均无统计学意义(x2=0.277,1.052,1.996,1.552,2.172,2.594,2.244,3.771,1.627,3.223,P>0.05)。(5)随访情况:262例患者术后 2个月获得随访,随访期间未见肿瘤复发,腹腔镜组1例患者因严重感染死亡。
    结论:Clavien-Dindo分级可用于达芬奇机器人手术系统和腹腔镜辅助全胃D2根治术后近期并发症评估,达芬奇机器人手术系统辅助全胃D2根治术比腹腔镜具有更好的微创优势,术后总体并发症和严重并发症更低。

     

    Abstract: Objective:To investigate the application value of Clavien-Dindo classification in evaluation of postoperative short-term complications of Da Vinci robotic-assisted or laparoscopic-assisted total gastrectomy with D2 lymphadenectomy.
    Methods:The retrospective cohort study was conducted. The clinicopathological data of 262 patients with gastric cancer who were admitted to the 940th Hospital of Joint Logistic Support Force of Chinese People′s Liberation Army from January 2016 to January 2019 were collected. There were 214 males and 48 females, aged (58±11) years, with a range from 17 to 81 years. Of 262 patients, 120 cases undergoing Da Vinci robotic-assisted total gastrectomy + D2 lymphadenectomy + Roux-en-Y anastomosis were divided into robotic group, and 142 cases undergoing laparoscopic-assisted total gastrectomy + D2 lymphadenectomy + Roux-en-Y anastomosis were divided into laparoscopic group. Observation indicators: (1) intraoperative and postoperative situations; (2) postoperative pathological examination; (3)complications; (4) stratified analysis; (5) follow-up. Follow-up using outpatient examination and telephone interview was performed to detect complications, tumor recurrence and survival of patients within postoperative 2 months. The follow-up was up to May 2019. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M (range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Comparison of ranked data between groups was analyzed using the rank sum test.
    Results:(1) Intraoperative and postoperative situations: cases undergoing conversion to open surgery, the operation time, volume of intraoperative blood loss, the number of lymph node dissected, time to first flatus, time to initial fluid diet intake, duration of postoperative hospital stay of the robotic group were 1, (243±42)minutes, 100 mL(range, 100-150 mL), 38±15, (2.8±1.0)days, 3 days(range, 3-4 days), 11 days(range, 9-13 days), respectively. The above indicators of the laparoscopic group were 2, (244±38)minutes, 100 mL(range, 100-150 mL), 34±14, (3.2±1.0)days, 4 days(range, 3-5 days), 10 days(range, 9-13 days), respectively. There were significant differences in the number of lymph node dissected, time to first flatus, time to initial fluid diet intake between the two groups (t=2.068, -3.030, Z=-3.370, P<0.05), and there was no significant difference in cases undergoing conversion to open surgery, the operation time, volume of intraoperative blood loss, duration of postoperative hospital stay between the two groups (x2=0.000, t=-0.158, Z=-1.824, -0.088, P>0.05). (2) Postoperative pathological examination: cases with well differentiated tumor, moderately differentiated tumor, poorly differentiated tumor, signet ring cell carcinoma or other types of tumor, cases in stage T1b, T2, T3 or T4a (pT staging), cases in stage N0, N1, N2, N3a or N3b (pN staging), cases in stage ⅠB, ⅡA, ⅡB, ⅢA, ⅢB or ⅢC (pTNM staging) of the robotic group were 6, 50, 55, 9, 10, 22, 63, 25, 42, 19, 19, 24, 16, 17, 22, 23, 20, 23, 15, respectively. The above indicators of the laparoscopic group were 4, 42, 84, 12, 6, 18, 81, 37, 39, 27, 32, 19, 25, 13, 19, 28, 39, 16, 27, respectively. There was no significant difference in the above indicators between the two groups (Z=-1.880, -1.827, -0.140, -1.460, P>0.05). (3) Complications: cases with complication classified as grade Ⅰ, grade Ⅱ, grade Ⅲa, grade Ⅲb, grade Ⅳa, grade Ⅳb of Clavien-Dindo classification, cases with death, cases with overall complications, cases with severe complications of the robotic group were 9, 6, 3, 2, 2, 0, 0, 22, 7, respectively. The above indicators of the laparoscopic group were 12, 15, 9, 6, 3, 1, 1, 47, 20, respectively. There were significant differences in cases with overall complications, cases with severe complications between the two groups (x2=7.309, 4.790, P<0.05), and there was no significant difference in cases with complication classified as grade Ⅰ, grade Ⅱ, grade Ⅲa, grade Ⅲb, grade Ⅳa, grade Ⅳb of Clavien-Dindo classification, cases with death between the two groups (x2=0.080, 2.730, 1.042, 0.704, 0.000, 0.000, 0.000, P>0.05). (4) Stratified analysis: of the patients with overall complications in robotic group, cases of male or female, cases aged ≥65 years or <65 years, cases with body mass index (BMI) ≥24 kg/m2 or <24 kg/m2, cases with tumor diameter ≥5 cm or <5 cm, cases with or without abdominal surgery, cases with tumor located at upper stomach or middle stomach, cases in Ⅰ-Ⅱ grade or Ⅲ grade of American Society of Anesthesiologists (ASA) classification, cases with well differentiated tumor or undifferentiated tumor, cases in stage Ⅰ-Ⅱ or stage Ⅲ (pTNM staging), cases with operation time ≥250 minutes or <250 minutes, cases with volume of intraoperative blood loss ≥150 mL or <150 mL, cases with the number of lymph node dissected ≥25 or <25 were 15, 7, 14, 8, 11, 11, 16, 6, 4, 18, 19, 3, 15, 7, 7, 15, 8, 14, 12, 10, 12, 10, 14, 8, respectively. The above indicators of patients with overall complications in the laparoscopic group were 33, 14, 17, 30, 16, 31, 36, 11, 11, 36, 27, 20, 31, 16, 13, 34, 14, 33, 24, 23, respectively. Of the patients with overall complication, there were significant differences in cases of male, cases aged ≥65 years or <65 years, cases with BMI<24 kg/m2, cases with tumor diameter≥5 cm, cases without abdominal surgery, cases with tumor located at middle stomach, cases in Ⅰ-Ⅱ grade or Ⅲ grade of ASA classification, cases with well differentiated tumor, cases in stage Ⅲ (pTNM staging), cases with operation time ≥250 minutes, cases with volume of intraoperative blood loss <150 mL, cases with the number of lymph node dissected ≥25 between the two groups (x2=6.683, 4.207, 6.761, 7.438, 4.297, 6.325, 9.433, 3.970, 4.850, 4.911, 3.952, 3.915, 6.865, 4.128, P<0.05) and there was no significant difference in cases of female, cases with BMI≥24 kg/m2, cases with tumor diameter <5 cm, cases with abdominal surgery, cases with tumor located at upper stomach, cases with undifferentiated tumor, cases in stage Ⅰ-Ⅱ (pTNM staging), cases with operation time < 250 minutes, cases with volume of intraoperative blood loss ≥150 mL, cases with the number of lymph node dissected <25 between the two groups (x2=0.277, 1.052, 1.996, 1.552, 2.172, 2.594, 2.244, 3.771, 1.627, 3.223, P>0.05). (5) Follow-up: 262 patients were followed up postoperatively for 2 months. During the follow-up, no patient was diagnosed with tumor recurrence, and one patient in the laparoscopic group died of severe infection.
    Conclusions:
    The Clavien-Dindo classification can be used in evaluating postoperative short-term complications of Da Vinci robotic-assisted or laparoscopic-assisted total gastrectomy with D2 lymphadenectomy. Compared with laparoscopic-assisted total gastrectomy with D2 lymphadenectomy, Da Vinci robotic-assisted total gastrectomy with D2 lymphadenectomy has the advantages of minimally invasiveness, low incidence of overall and severe complication.

     

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