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单孔与多孔腹腔镜远端胃癌根治术的随机对照研究。

A randomized controlled trial of single-port versus multi-port laparoscopic distal gastrectomy for gastric cancer.

机构信息

Department of Gastroenterological Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.

出版信息

Surg Endosc. 2021 Aug;35(8):4485-4493. doi: 10.1007/s00464-020-07955-0. Epub 2020 Sep 4.

Abstract

OBJECTIVE

This prospective randomized trial compared the invasiveness of laparoscopic gastrectomy using a single-port approach with that of a conventional multi-port approach in the treatment of gastric cancer. The benefit of single-port laparoscopic gastrectomy (SLG) over multi-port laparoscopic gastrectomy (MLG) has yet to be confirmed in a well-designed study.

METHODS

One hundred and one patients who were scheduled to undergo laparoscopic distal gastrectomy for histologically confirmed clinical stage I gastric cancer between April 2016 and September 2018 were randomly allocated to SLG (n = 50) or MLG (n = 51). The primary endpoints were the postoperative visual analog scale pain scores. Secondary endpoints were frequency of use of analgesia, short-term outcomes, such as operating time, intraoperative blood loss, inflammatory reactions, postoperative morbidity, and 90-day mortality.

RESULTS

The postoperative pain score was significantly lower in the SLG group than in the MLG group (p < 0.001) on the operative day and the postoperative day 1-7. Analgesics were administered significantly less often in the SLG group than in the MLG group (1 vs. 3 days, p = 0.0078) and the duration of use of analgesics was significantly shorter in the SLG group (2 vs. 3 days, p = 0.0171). The operating time was significantly shorter in the SLG group than in the MLG group (169 vs. 182 min, p = 0.0399). Other surgical outcomes were comparable between the study groups.

CONCLUSIONS

SLG was shown to be safe and feasible in the treatment of gastric cancer with better short-term results in terms of less severe pain and may be suitable for treatment of cStage I gastric cancer.

CLINICAL TRIAL REGISTRATION

UMIN000022218.

摘要

目的

本前瞻性随机试验比较了单孔腹腔镜胃癌根治术与传统多孔腹腔镜胃癌根治术的侵袭性,胃癌的单孔腹腔镜胃癌根治术(SLG)优于多孔腹腔镜胃癌根治术(MLG)的优势尚未在设计良好的研究中得到证实。

方法

2016 年 4 月至 2018 年 9 月,101 例经组织学证实为临床 I 期胃癌的患者被随机分配至 SLG(n=50)或 MLG(n=51)组。主要终点为术后视觉模拟评分疼痛。次要终点为镇痛使用频率、手术时间、术中出血量、炎症反应、术后发病率和 90 天死亡率等短期结果。

结果

与 MLG 组相比,SLG 组术后疼痛评分在手术当天和术后第 1-7 天均显著降低(p<0.001)。SLG 组的镇痛药物使用次数明显少于 MLG 组(1 天对 3 天,p=0.0078),SLG 组的镇痛药物使用时间明显短于 MLG 组(2 天对 3 天,p=0.0171)。SLG 组的手术时间明显短于 MLG 组(169 分钟对 182 分钟,p=0.0399)。两组的其他手术结果相当。

结论

SLG 治疗胃癌安全可行,短期结果显示疼痛较轻,可能适合治疗 cI 期胃癌。

临床试验注册

UMIN000022218。

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