中国经肛全直肠系膜切除手术病例登记协作研究数据库2018年度报告:一项全国性登记研究

Annual report of Chinese Transanal Total Mesorectal Excision Registry Collaborative in 2018: A nationwide registry study

目的介绍并评估基于全国性登记系统经肛全直肠系膜切除(TaTME)手术病例的术后短期临床病理学疗效。方法基于真实世界研究的理念,通过回顾性及前瞻性收集并分析2017-11-15至2018-06-30来自全国性、多中心登记录入中国TaTME病例登记协作研究数据库(CTRC)的601例TaTME手术病例,评估TaTME手术的安全性、有效性。结果 (1)601例中男性病人占68.7%,年龄为(59.5±11.4)岁,BMI为23.9±3.6;其中有558例为直肠癌病人,直肠肿瘤下缘距肛缘的平均距离为(48.1±14.8)mm,直肠癌病人接受新辅助治疗的比例为31.7%。(2)24.6%的直肠癌手术病例是在专家指导下完成,出血量为(115.2±366.5)mL,手术时间为(247.1±87.5)min,使用吻合器吻合占74.8%,施行预防造口的比例为49.6%,不稳定的盆腔CO_2灌注压力、盆腔术野烟雾为最常见的术中困难;术者对直肠癌病人TaTME手术标本系膜完整性评估为完整、近乎完整、不完整的比例分别为79.6%、16.8%、0.2%。(3)直肠癌病人术后并发症发生率为20.2%,吻合口漏发生率为7.0%。(4)共有8例标本发生穿孔,淋巴结检出数目为(15.4±7.9)枚。结论术后短期的临床病理学结果显示,TaTME手术安全有效,能够保证下端直肠系膜切除的完整性、环周切缘以及远端切缘的安全性。然而,CTRC数据质量仍须改善,TaTME手术的结构化培训不可或缺,尚须进一步的全国性多中心前瞻性临床试验评价TaTME手术与TME手术的疗效差别。

Objective to introduce the study method of Chinese Transanal Total Mesorectal Excision(TaTME) registry Collaborative(CTRC),and report the short-term clinical-oncological outcomes from CTRC. Methods Based upon the concept of real world evidence,Data of 601 cases were retrospectively and prospectively analyzed from a nationwide multi-center registry system of CTRC. The safety and effectiveness of these cases were evaluated. Results The results of the CTRC database showed that: (1) 68.7% of 601 patients were male,the average age of all patients was (59.5±11.4)years,the average BMI was 23.9±3.6. There were 558 cases of rectal cancer among the total enrolled cases. The average distance between the distal edge of rectal cancer and the anal verge was (48.1±14.8)mm,and the ratio of neoadjuvant therapy was 31.7%. (2) 24.6% of the surgical cases were completed under the supervision of TaTME experts. The mean volume of intraoperative blood loss was (115.2±366.5)mL,and the mean operating time was (247.1±87.5)min. Circle stapler was used to make the anastomosis among 74.8% of rectal cancer cases. The protective stoma was performed among 49.6% of the cases of rectal cancer. Maintaining a stable pneumopelvis and excessive smoke obscuring the pelvic view,were the main intraoperative difficulties encountered during transanal procedure. According to the grading of quality and completeness of the mesorectum in the total mesorectal excision specimen,the incidence rates of TaTME specimen graded as "complete","nearly complete" and "incomplete" were 79.6%,16.8% and 0.2% respectively by the evaluation of surgeons. (3)The incidence of postoperative complications was 20.2%,and the anastomotic leakage rate was 7.0%. (4) There were 8 cases of specimen perforation. The average number of lymph node harvest was 15.4±7.9. Conclusion TaTME procedure seems be safe and effective regarding to the short-term clinical-pathological outcomes. The completeness of distal mesorectal dissection,circumferential resection margin and distal resection margin can be promised by the procedure of TaTME. However,the data quality in the database of CTRC needs to be improved,and structured training for TaTME surgery is indispensable. Further national multicenter prospective clinical trials are needed to evaluate the efficacy of TaTME versus TME.