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乙状结肠癌单孔腹腔镜结肠切除术的安全性和有效性:一项II期临床试验

Safety and efficacy of single-port colectomy for sigmoid colon cancer: a phase II clinical trial.

作者信息

Park Ji Won, Sohn Dea Kyung, Park Sohee, Park Sung Chan, Chang Hee Jin, Son Hae-Jung, Oh Jae Hwan

机构信息

Center for Colorectal Cancer, Research Institute & Hospital, National Cancer Center, Goyang, Korea.

出版信息

J Laparoendosc Adv Surg Tech A. 2013 Sep;23(9):745-50. doi: 10.1089/lap.2013.0209. Epub 2013 Aug 12.

DOI:10.1089/lap.2013.0209
PMID:23937142
Abstract

BACKGROUND

Recently, single-port surgery for colon cancer has been increasingly attempted. However, prospective studies investigating the efficacy of single-port colectomy for colon cancer are lacking. The aim of this study is to determine whether single-port colectomy for sigmoid colon cancer is a safe and effective surgical option.

SUBJECTS AND METHODS

Forty-eight patients were enrolled for this prospective single-arm Phase II trial. All patients underwent single-port laparoscopic-assisted sigmoidectomy through the umbilicus. The primary outcome was the number of retrieved lymph nodes. Secondary measures included the conversion rate, postoperative morbidities, mortalities, and short-term clinical outcomes.

RESULTS

The mean number of retrieved lymph nodes was 21.1 (95% confidence interval, 18.1-23.99). The conversion rate was 14.6% (open conversion, 4.2%), and the overall proportion of morbidity was 31.2%. The majority of complications involved wound problems (18.8%); the mortality rate was 0%. The median postoperative hospital stay was 8 days (range, 7-12 days), and the median time from surgery until the first episode of flatus was 3 days (range, 1-5 days).

CONCLUSIONS

Single-port colectomy for sigmoid colon cancer is safe and oncologically feasible in selected patients. Considering the relatively high conversion rates, improvement of the instruments for single-port colectomy is needed.

摘要

背景

最近,结肠癌的单孔手术越来越多地被尝试。然而,缺乏对结肠癌单孔结肠切除术疗效进行调查的前瞻性研究。本研究的目的是确定乙状结肠癌的单孔结肠切除术是否是一种安全有效的手术选择。

对象与方法

48例患者入选了这项前瞻性单臂II期试验。所有患者均通过脐部进行单孔腹腔镜辅助乙状结肠切除术。主要结局是获取的淋巴结数量。次要指标包括中转率、术后发病率、死亡率和短期临床结局。

结果

获取的淋巴结平均数量为21.1个(95%置信区间,18.1 - 23.99)。中转率为14.6%(开放中转,4.2%),总体发病率为31.2%。大多数并发症涉及伤口问题(18.8%);死亡率为0%。术后中位住院时间为8天(范围,7 - 12天),从手术到首次排气的中位时间为3天(范围,1 - 5天)。

结论

对于选定的患者,乙状结肠癌的单孔结肠切除术是安全的且在肿瘤学上可行。考虑到相对较高的中转率,需要改进单孔结肠切除术的器械。

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