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单切口与多端口腹腔镜结肠切除术随机临床试验后的疝发生率

Hernia incidence following a randomized clinical trial of single-incision versus multi-port laparoscopic colectomy.

作者信息

Watanabe Jun, Ishibe Atsushi, Suwa Yusuke, Suwa Hirokazu, Ota Mitsuyoshi, Kubota Kazumi, Yamanaka Takeharu, Kunisaki Chikara, Endo Itaru

机构信息

Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.

Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.

出版信息

Surg Endosc. 2021 Jun;35(6):2465-2472. doi: 10.1007/s00464-020-07656-8. Epub 2020 May 20.

Abstract

BACKGROUND

The short-term results of single-incision laparoscopic colectomy (SILC) showed the safety, feasibility, and effectiveness when performed by skilled laparoscopic surgeons. However, the long-term complications, such as SILC-associated incisional hernia, have not been evaluated. The aim of this study was to determine the incidence of incisional hernia after SILC compared with multi-port laparoscopic colectomy (MPC) for colon cancer.

METHODS

From March 2012, to March 2015, a total of 200 patients were enrolled in this study. The patients were randomized to the MPC arm and SILC arm. A total of 200 patients (MPC arm; 100 patients, SILC arm; 100 patients) were therefore analyzed. In all cases the specimen was extracted through the umbilical port, which was extended according to the size of the specimen. A diagnosis of incisional hernia was made either based on a physical examination or computed tomography.

RESULTS

The baseline factors were well balanced between the arms. The median follow-up period was 42.4 (range 9.4-70.0) months. Twenty-one patients were diagnosed with incisional hernia, giving an incidence rate of 12.1% in the MPC arm and 9.0% in the SILC arm at 36 months (P = 0.451). In the multivariate analysis, the body mass index (≥ 25 kg/m) (hazard ratio [HR] 3.03; 95% confidence interval [CI] 1.03-8.92; P = 0.044), umbilical incision (≥ 5.0 cm) (HR 3.22; 95% CI 1.16-8.93; P = 0.025), and history of umbilical hernia (HR 3.16; 95% CI 1.02-9.77; P = 0.045) were shown to be correlated with incisional hernia.

CONCLUSIONS

We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port. The study was registered with the Japanese Clinical Trials Registry as UMIN000007220.

摘要

背景

单切口腹腔镜结肠切除术(SILC)的短期结果显示,由技术熟练的腹腔镜外科医生实施该手术时具有安全性、可行性和有效性。然而,诸如与SILC相关的切口疝等长期并发症尚未得到评估。本研究的目的是确定与多端口腹腔镜结肠切除术(MPC)相比,SILC术后结肠癌患者切口疝的发生率。

方法

从2012年3月至2015年3月,共有200例患者纳入本研究。将患者随机分为MPC组和SILC组。因此,共分析了200例患者(MPC组100例,SILC组100例)。所有病例的标本均通过脐部切口取出,脐部切口根据标本大小进行延长。切口疝的诊断基于体格检查或计算机断层扫描。

结果

两组间基线因素均衡。中位随访期为42.4(9.4 - 70.0)个月。21例患者被诊断为切口疝,36个月时MPC组的发生率为12.1%,SILC组为9.0%(P = 0.451)。多因素分析显示,体重指数(≥25 kg/m²)(风险比[HR] 3.03;95%置信区间[CI] 1.03 - 8.92;P = 0.044)、脐部切口(≥5.0 cm)(HR 3.22;95% CI 1.16 - 8.93;P = 0.025)和脐疝病史(HR 3.16;95% CI 1.02 - 9.77;P = 0.045)与切口疝相关。

结论

我们发现长期随访后,SILC组与MPC组切口疝的发生率无显著差异。然而,由于所有标本均通过脐部切口取出,该结果可能存在偏倚。本研究已在日本临床试验注册中心注册,注册号为UMIN000007220。

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