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腹腔镜右半结肠切除术患者行体腔内吻合与体腔外吻合的多中心随机临床试验(IVEA 研究)。

Intracorporeal Versus Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: A Multicenter Randomized Clinical Trial (The IVEA-study).

机构信息

Department of General Surgery, Division of Colorectal Surgery, University Hospital of Torrecárdenas, Almeria.

Department of General Surgery, Division of Colorectal Surgery, University General Hospital, Elche.

出版信息

Surg Laparosc Endosc Percutan Tech. 2021 May 3;31(4):408-413. doi: 10.1097/SLE.0000000000000937.

Abstract

OBJECTIVE

The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm.

BACKGROUND

Despite advances in the laparoscopic approach in colorectal surgery and the clear benefit of this approach over open surgery, because of the technical difficulty in performing intracorporeal anastomosis (IA), some continue to perform it extracorporeally in right colon surgery.

MATERIALS AND METHODS

This study was a prospective multicenter randomized trial with 2 parallel groups on which either IA or extracorporeal anastomosis was performed in laparoscopic right hemicolectomy for right colon neoplasm, carried out between January 2016 and December 2018.

RESULTS

A total of 168 patients were randomized during the study period. At baseline, the 2 groups were comparable for age, sex, body mass index, surgical risk, and comorbidity. The median length of postoperative hospital stay was 7 days with no differences between the groups. About 70% of patients had an uneventful postoperative period without complications. The most common complications were paralytic ileus (20.63%; 33), surgical site infection (SSI) (10%; 16), and anastomotic leakage (6.25%; 10). The results show a lower level of SSI in the IA group (3.65% vs. 16.67%, P=0.008). Other complications do not show statistically significant differences between groups. Likewise, the incision for the extraction of the specimen was smaller in the IA group (P=0.000) and creation of the anastomosis intracorporeally decreased postoperative pain (P=0.000).

CONCLUSIONS

In comparison to the extracorporeal technique, IA decreased postoperative pain, incision size, and SSI. Further studies will be needed to verify our findings.

摘要

目的

本研究旨在评估腹腔镜右半结肠切除术治疗右半结肠癌时行腔内吻合与腔外吻合的短期疗效。

背景

尽管腹腔镜结直肠手术取得了进展,且该术式明显优于开放手术,但由于腔内吻合(IA)技术难度较大,一些外科医生仍继续在右半结肠癌手术中进行腔外吻合。

材料与方法

这是一项前瞻性多中心随机试验,采用 2 个平行组,分别行腹腔镜右半结肠切除术治疗右半结肠癌时行腔内吻合或腔外吻合,研究时间为 2016 年 1 月至 2018 年 12 月。

结果

研究期间共随机分配 168 例患者。基线时,2 组患者的年龄、性别、体重指数、手术风险和合并症相当。术后住院时间中位数为 7 天,组间无差异。约 70%的患者术后无并发症,恢复顺利。最常见的并发症是麻痹性肠梗阻(20.63%,33 例)、手术部位感染(SSI)(10%,16 例)和吻合口漏(6.25%,10 例)。结果显示 IA 组 SSI 发生率较低(3.65%比 16.67%,P=0.008)。组间其他并发症无统计学差异。同样,IA 组标本取出切口较小(P=0.000),腔内吻合可减少术后疼痛(P=0.000)。

结论

与腔外技术相比,IA 可减轻术后疼痛、减小切口大小和降低 SSI 发生率。需要进一步研究来验证我们的发现。

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