Objective: To evaluate the mid-term efficacy of laparoscopic-assisted natural orifice specimen extraction surgery (NOSES) colectomy using the Cai tube in the treatment of left colorectal cancer. Methods: A prospective randomized control trial (China Clinical Trials Registration Number: ChiCTR-OOR-15007060) was performed. Sixty patients with left colorectal cancer at Department of Gastrointestinal Surgery of Zhongshan Hospital from September 2015 to August 2017 were prospectively enrolled. Case inclusion criteria: (1) left colorectal adenocarcinoma (rectal cancer with distance ≥ 8 cm from tumor low margin to anal edge, sigmoid colon cancer, descending colon cancer and left transverse colon cancer) confirmed by preoperative pathology; (2) satisfactory conditions of conventional laparoscopic surgery; (3) maximum diameter of the tumor < 4.5 cm confirmed by preoperative abdominal and pelvic CT or MRI; (4) BMI < 30 kg/m2. Case exclusion criteria: (1) benign lesions, mucinous adenocarcinoma, signet-ring cell carcinoma and other special pathological types of tumors confirmed by preoperative pathological examination; (2) multiple or recurrent cancers; (3) with a history of neoadjuvant chemoradiotherapy; (4) obvious regional infiltration or distant metastasis indicated by preoperative imaging examination; (5) intestinal obstruction, intestinal perforation, etc. Participants were randomly assigned to NOSES group (using the Cai tube) and conventional laparoscopy (CL) group by random number table method. Clinical data between two groups were compared and analyzed, including perioperative conditions, tumor exfoliation cell detection and bacterial culture results of intraperitoneal lavage fluid, postoperative complications (Clavien-Dindo grading), postoperative pain [visual simulation scoring (VAS) assessment], anal function (Kirwan anal function grading assessment), and postoperative 3-year disease-free survival (DFS), overall survival (OS), overall recurrence rate, and local recurrence rate. Results: A total of 60 patients were enrolled, with 30 in the NOSES group and 30 in the CL group. All the patients in the NOSES group successfully completed operation with Cai tube. Baseline data between the two groups were not significantly different (all P>0.05). There were no statistically significant differences between two groups in conversion rate to open surgery, number of lymph node harivested, proximal and distal resection margin of tumor, negative rate of circumferential margin, operation time, blood loss, inflammatory indexes, postoperative anal function, postoperative hospital stay, hospitalization cost, morbidity of postoperative complications (Clavien-Dindo grade II or above) (all P>0.05). Compared to the CL group, the NOSES group had lower maximum postoperative VAS score (2.5±0.3 vs. 5.1±0.4, t=3.187, P<0.01), and fewer use of additional postoperative analgesia [6.7% (2/30) vs. 33.3% (10/30),χ2=6.670, P=0.02]. The postoperative time to gas passage was shorter in the NOSES group [(2.2±1.4) days vs. (3.1±1.2) days,P=0.026]. No tumor cells and bacterial contamination were found in abdominal lavage fluid before and after operation in either group. The anal function at postoperative 3-month of all the patients in the NOSES group was Kirwan grade I to II, while in the CL group, anal function of 2 cases (6.7%) was Kirwan grade III, and of 28 cases was also Kirwan grade I to II, whose difference was not statistically significant (P>0.05). In the NOSES group and the CL group, 3-year DFS was 96.7% and 83.3% (P=0.090), OS was 100% and 90% (P=0.096), overall recurrence rate was 3.3% and 10.0% (P=0.166), and local recurrence rate was 3.3% and 3.3% (P=0.999), respectively, whose differences were not statistically significant (all P>0.05). Conclusions: In the treatment of left colorectal cancer, compared with conventional laparoscopic colectomy, NOSES colectomy using Cai tube exhibits less scar, less postoperative pain, shorter recovery of gastrointestinal function, and similar mid-term outcomes. Given proper surgical indications, the surgical procedure is safe and feasible.
目的： 总结左结直肠癌根治术应用蔡氏套管器经自然腔道取标本（NOSES）与传统腹腔镜手术随机对照研究的中期疗效。 方法： 采用前瞻性随机对照研究的方法（中国临床试验注册号：ChiCTR-OOR-15007060）。纳入厦门大学附属中山医院胃肠外科2015年9月至2017年8月期间收治的60例左结直肠癌患者。病例纳入标准：（1）术前病理学证实为左结直肠腺癌（肿瘤下缘距肛缘≥8 cm的直肠癌、乙状结肠癌、降结肠癌和左半横结肠癌）；（2）满足行传统腹腔镜手术的条件；（3）术前腹盆腔CT（或MRI）示肿瘤最大径<4.5 cm；（4）体质指数<30 kg/m2。排除标准：（1）术前病理检查证实为良性病变、黏液腺癌或印戒细胞癌等特殊病理类型的肿瘤；（2）多发或复发癌；（3）有新辅助放化疗史；（4）术前辅助检查提示局部明显浸润或有远处转移；（5）合并肠梗阻、肠穿孔等情况。采用随机数字表法进行分组为NOSES手术组（应用蔡氏套管器完成手术）和传统腹腔镜手术组，对两组患者的临床资料包括围手术期情况、腹腔灌洗液和肿瘤脱落细胞检测及细菌培养结果、术后并发症发生情况（采用Clavien-Dindo分级）、术后疼痛情况［采用视觉模拟评分法（VAS）评估］、肛门功能（Kirwan肛门功能分级评估）以及术后3年无病生存率（DFS）、总体生存率（OS）、总体复发率和局部复发率进行分析比较。 结果： 共60例患者入组研究NOSES手术组和传统腹腔镜手术组各30例，两组基本资料的比较，差异无统计学意义（均P>0.05）。两组患者中转开腹率、淋巴结清扫数、远近切缘距肿瘤距离、环周切缘阴性率、手术时间、出血量、炎性指标、术后住院时间以及术后并发症发生率（Ⅱ级以上）的比较，差异均无统计学意义（均P>0.05）；与传统腹腔镜手术组比较，NOSES组术后最大VAS评分［（2.5±0.3）分比（5.1±0.4）分，t=3.187，P<0.01］及镇痛泵外止痛药使用率［6.7%（2/30）比33.3%（10/30），χ2=6.670，P=0.02］均明显较低（P<0.05）；术后首次排气时间较短［（2.2±1.4）d比（3.1±1.2）d，P=0.026］。两组患者术前及术后腹腔灌洗液中均未发现肿瘤细胞和细菌污染。NOSES组术后3个月肛门功能均为KirwanⅠ~Ⅱ级，传统腹腔镜手术组除2例（6.7%）术后3个月肛门功能为Kirwan Ⅲ级外，其余28例也均为KirwanⅠ~Ⅱ级，两组肛门功能评级比较，差异无统计学意义（P>0.05）。NOSES组与传统腹腔镜手术组3年DFS分别为96.7%和83.3%（P=0.090），OS分别为100%和90.0%（P=0.096），总体复发率分别为3.3%和10.0%（P=0.166），局部复发率分别为3.3%和3.3%（P=0.999），差异均无统计学意义（均P>0.05）。 结论： 应用蔡氏套管器的NOSES左结直肠癌根治术作为一种经自然腔道取标本的手术，具有无明显手术瘢痕、术后疼痛明显减轻、胃肠道功能恢复更快的优势；术后3年随访疗效满意。在把握好手术适应证的前提下，该术式安全可行。.