Chen Z Z, Ding Z J, Wang Z F, Xu S Z, Zhang S F, Yuan S S, Yan F, Liu G Y, Qiu X F, Cai J C
Department of Gastrointestinal Surgery, Zhongshan Hospital, Xiamen University; Institute of Gastrointestinal Oncology, Medical College of Xiamen University; Xiamen Municipal Key Laboratory of Gastrointestinal Oncology, Xiamen 361004, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Aug 25;26(8):768-772. doi: 10.3760/cma.j.cn441530-20230406-00103.
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. 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/m. 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. 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 (=0.455); disease free survival was 90.0% and 83.3%, respectively (=0.455); overall recurrence rate 6.6% and 10.0%, respectively (=0.625); and local recurrence rate both were 3.3% (=0.990), respectively. None of these differences was statistically significant. NOSES and CLS have similar long-term efficacy, and NOSES deserves to be used in clinical practice.
评估使用蔡氏管的腹腔镜辅助经自然腔道取标本手术(NOSES)结肠切除术治疗左侧结直肠癌的长期疗效。这是一项随机对照试验。纳入标准如下:术前病理诊断为左侧结直肠腺癌(直肠、乙状结肠、降结肠或距肛缘尾侧边缘≥8 cm的左半横结肠癌);术前腹部和盆腔计算机断层扫描(或磁共振成像)显示最大肿瘤直径<4.5 cm;且体重指数<30 kg/m²。排除患有同步多发原发性癌症或复发性癌症、有新辅助放化疗史、术前有明显局部浸润、远处转移或肠梗阻和肠穿孔等并发症的患者,或其他不适合腹腔镜手术的患者。使用随机数字表将连续患者随机分为使用蔡氏管的NOSES手术(非辅助切口肛门袖套:专利号ZL201410168748.2)(NOSES组)或传统腹腔镜辅助手术(CLS组)。分析两组患者的相关临床数据,主要结局为术后5年的无病生存率、总生存率、总复发率和局部复发率。两个研究组的患者均成功完成手术,无需额外手术。术后平均随访70(7 - 83)个月,NOSES组和CLS组术后5年总生存率分别为90.0%和83.3%(P = 0.455);无病生存率分别为90.0%和83.3%(P = 0.455);总复发率分别为6.6%和10.0%(P = 0.625);局部复发率均为3.3%(P = 0.990)。这些差异均无统计学意义。NOSES和CLS具有相似的长期疗效,NOSES值得在临床实践中应用。