Data_Sheet_1_Safety and Oncological Outcomes of Laparoscopic NOSE Surgery Compared With Conventional Laparoscopic Surgery for Colorectal Diseases: A Meta-Analysis.docx

Objective: To evaluate the safety and oncological outcomes of laparoscopic colorectal surgery using natural orifice specimen extraction (NOSE) compared with conventional laparoscopic (CL) colorectal surgery in patients with colorectal diseases.
Methods: We conducted a systematic search of PubMed, EMBASE, and Cochrane databases for randomized controlled trials (RCTs), prospective non-randomized trials and retrospective trials up to September 1, 2018, and used 5-year disease-free survival (DFS), lymph node harvest, surgical site infection (SSI), anastomotic leakage, and intra-abdominal abscess as the main endpoints. Subgroup analyses were conducted according to the different study types [RCT and NRCT (non-randomized controlled trial)]. A sensitivity analysis was carried out to evaluate the reliability of the outcomes. RevMan5.3 software was used for statistical analysis.
Results: Fourteen studies were included (two RCTs, seven retrospective trials and five prospective non-randomized trials) involving a total of 1,435 patients. Compared with CL surgery, the NOSE technique resulted in a shorter hospital stay, shorter time to first flatus, less post-operative pain, and fewer SSIs and total perioperative complications. Anastomotic leakage, blood loss, and intra-abdominal abscess did not differ between the two groups, while operation time was longer in the NOSE group. Oncological outcomes such as proximal margin [weighted mean difference [WMD] = 0.47; 95% confidence interval [CI] −0.49 to 1.42; P = 0.34], distal margin (WMD= −0.11; 95% CI −0.66 to 0.45; P = 0.70), lymph node harvest (WMD = −0.97; 95% CI −1.97 to 0.03; P = 0.06) and 5-year DFS (hazard ratio = 0.84; 95% CI 0.54–1.31; P = 0.45) were not different between the NOSE and CL surgery groups.
Conclusions: Compared with CL surgery, NOSE may be a safe procedure, and can achieve similar oncological outcomes. Large multicenter RCTs are needed to provide high-level, evidence-based results in NOSE-treated patients and to determine the risk of local recurrence.

研究目的：评估采用经自然腔道取标本手术（natural orifice specimen extraction, NOSE）的腹腔镜结直肠手术，对比常规腹腔镜（conventional laparoscopic, CL）结直肠手术在结直肠疾病患者中的安全性与肿瘤学结局。
研究方法：本研究对PubMed、EMBASE及Cochrane数据库进行系统检索，检索时限截至2018年9月1日，纳入随机对照试验（randomized controlled trial, RCT）、前瞻性非随机试验及回顾性试验，以5年无病生存期（disease-free survival, DFS）、淋巴结清扫数、手术部位感染（surgical site infection, SSI）、吻合口漏及腹腔内脓肿作为主要研究终点。按研究类型（RCT与非随机对照试验non-randomized controlled trial, NRCT）开展亚组分析，并通过敏感性分析评估研究结局的可靠性，采用RevMan5.3软件进行统计学分析。
研究结果：共纳入14项研究（2项RCT、7项回顾性试验及5项前瞻性非随机试验），涉及总样本量1435例患者。与CL手术相比，NOSE术式可缩短住院时长、加快首次排气时间、减轻术后疼痛，且手术部位感染与围手术期总并发症发生率更低。两组在吻合口漏、失血量及腹腔内脓肿发生率方面无显著差异，但NOSE组的手术时间更长。肿瘤学结局方面，近切缘[加权均数差（weighted mean difference, WMD）=0.47；95%置信区间（confidence interval, CI）：-0.49~1.42；P=0.34]、远切缘（WMD=-0.11；95%CI：-0.66~0.45；P=0.70）、淋巴结清扫数（WMD=-0.97；95%CI：-1.97~0.03；P=0.06）及5年DFS[风险比（hazard ratio）=0.84；95%CI：0.54~1.31；P=0.45]在两组间均无统计学差异。
研究结论：与CL手术相比，NOSE术式安全性良好，且可获得相似的肿瘤学结局。未来需开展大型多中心RCT，为NOSE手术患者提供高质量的循证医学证据，并明确局部复发风险。