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经直肠自然腔道标本取出术(NOSE)的肿瘤安全性:一项前瞻性随机试验。

Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.

机构信息

Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

出版信息

J Surg Res. 2020 Oct;254:16-22. doi: 10.1016/j.jss.2020.03.064. Epub 2020 May 8.

Abstract

BACKGROUND

In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).

METHODS

A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.

RESULTS

A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.

CONCLUSIONS

The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.

摘要

背景

本研究旨在介绍经直肠自然腔道取标本(NOSE)在腹腔镜中上段直肠及乙状结肠癌根治术中的应用经验。

方法

前瞻性随机对照研究,自 2016 年 6 月至 2019 年 5 月共入组 276 例患者,随机分为经直肠自然腔道取标本组(NOSE 组,n=122)和传统腹腔镜组(n=119)。对比分析两组患者的术前及术后临床资料,采用视觉模拟评分(VAS)评估术后疼痛情况,采用 Kaplan-Meier 曲线分析术后总生存情况。

结果

NOSE 组 122 例中,22 例中转经腹取标本,最终纳入 122 例,NOSE 组和传统腹腔镜组的并发症发生率分别为 9%(11/122)和 21%(25/119),差异有统计学意义(P=0.024)。NOSE 组的手术时间长于传统腹腔镜组,术中出血量少于传统腹腔镜组,术后 VAS 评分低于传统腹腔镜组。NOSE 组患者术后通气时间和住院时间长于传统腹腔镜组,两组术后并发症发生率的差异有统计学意义(P=0.024)。两组患者术后的无病生存率比较,差异无统计学意义(P=0.411)。

结论

经直肠自然腔道取标本在腹腔镜中上段直肠及乙状结肠癌根治术中是安全可行的,与传统腹腔镜手术相比,NOSE 术后并发症发生率更低,患者短期临床恢复更好。

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