Objective: To evaluate the long-term efficacy of laparoscopic-assisted natural orifice specimen extraction surgery (NOSES) colectomy using Cai tube for treating left-sided colorectal cancer. Methods: This was a randomized controlled trial. Inclusion criteria were as follows: preoperative pathological diagnosis of left-sided colorectal adenocarcinoma (rectal, sigmoid colon, descending colon, or left transverse colon cancer with the caudad margin ≥8 cm from the anal margin); preoperative abdominal and pelvic computed tomography (or magnetic resonance imaging) showing maximum tumor diameter <4.5 cm; and BMI <30 kg/m2. Patients with synchronous multiple primary cancers or recurrent cancers, a history of neoadjuvant chemoradiotherapy, preoperative evidence of significant local infiltration, distant metastasis, or complications such as intestinal obstruction and intestinal perforation, or who were not otherwise considered suitable for laparoscopic surgery were excluded. A random number table was used to randomize sequential patients to NOSES surgery using Cai tube (non-assisted incision anal sleeve: patent number ZL201410168748.2) (NOSES group) or traditional laparoscopic-assisted surgery (CLS group). Relevant clinical data of the two groups of patients were analyzed, the main outcomes being disease-free survival, overall survival, overall recurrence rate, and local recurrence rate 5 years after surgery. Results: Patients in both study groups completed the surgery successfully with no requirement for additional surgery. After mean 70 (7-83) months postoperative follow-up, the 5-year overall postoperative survival in the NOSES and CLS groups was 90.0% and 83.3%, respectively (P=0.455); disease free survival was 90.0% and 83.3%, respectively (P=0.455); overall recurrence rate 6.6% and 10.0%, respectively (P=0.625); and local recurrence rate both were 3.3% (P=0.990), respectively. None of these differences was statistically significant. Conclusions: NOSES and CLS have similar long-term efficacy, and NOSES deserves to be used in clinical practice.
目的： 比较左结直肠癌腹腔镜辅助根治术应用蔡氏套管器经自然腔道取标本（NOSES）与传统腹腔镜辅助根治术（CLS）的长期疗效。 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）术前腹盆腔CT（或MRI）示肿瘤最大径<4.5 cm；（3）体质指数（BMI）<30 kg/m2。排除同时性多原发癌或复发癌、有新辅助放化疗史以及术前辅助检查提示局部明显浸润，或有远处转移，或合并肠梗阻、肠穿孔等情况不适于行腹腔镜手术者。采用随机数字表法，依次将纳入的患者中30例应用蔡氏套管器（免辅助切口肛门套管器：专利号ZL201410168748.2）完成NOSES手术（NOSES组），另30例进行传统腹腔镜辅助手术（CLS组），对两组患者的临床资料进行对比分析。主要观察指标为术后5年无病生存率（DFS）、总体生存率（OS）、总体复发率（OR）和局部复发率（LR）。 结果： NOSES组和CLS组患者均顺利完成手术，无中转手术者。术后随访平均70（7~83）个月，NOSES组与CLS组术后5年OS分别为90.0%和83.3%（P=0.455），5年DFS分别为90.0%和83.3%（P=0.455），5年OR分别为6.6%和10.0%（P=0.625），5年LR均为3.3%（P=0.990），差异均无统计学意义。 结论： 与CLS相比，NOSES具有相似的长期疗效，在临床上值得推广应用。.