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随机对照临床试验:腹腔镜右半结肠切除术的腔内吻合与腔外吻合比较(IEA 试验)。

Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).

机构信息

Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Department of Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.

出版信息

Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.

Abstract

BACKGROUND

Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy.

METHODS

An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes.

RESULTS

A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194).

CONCLUSION

Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).

摘要

背景

几项非随机和回顾性研究表明,在腹腔镜右半结肠切除术中,腔内吻合(IA)优于腔外吻合(EA),但缺乏科学证据。本研究旨在比较短期结果,并确定与 EA 相比,IA 在择期腹腔镜右半结肠切除术中的可能优势。

方法

本研究为一项 2015 年 5 月至 2018 年 6 月进行的 RCT。主要终点是住院时间。次要终点是术中技术事件和术后临床结果。

结果

共纳入 140 例患者,随机分为 IA 组和 EA 组。IA 组手术时间长于 EA 组(中位数 149(95-215)分钟 vs. 123(60-240)分钟;P<0.001)。IA 组的切口长度较短(中位数 6.7(4-9.5)厘米 vs. 8.7(5-13)厘米;P<0.001)。IA 组患者的消化功能恢复更快(中位数 2.3 天 vs. 3.3 天;P=0.003),术后麻痹性肠梗阻发生率较低(13% vs. 30%;P=0.022)。IA 组需要的术后镇痛药物较少(平均(标准差)加权镇痛需求 39(24)与 53(26);P=0.001),疼痛评分也较低(P=0.035)。术后血红蛋白水平下降较小(平均(标准差)8.8(1.7)毫克/分升 vs. 17.1(1.7)毫克/分升;P=0.001),下消化道出血发生率较低(3% vs. 14%;P=0.031)。IA 组的 I 级和 II 级并发症发生率明显较高(P=0.016 和 P=0.037)。IA 组的住院时间略短(中位数 5.7(范围 2-19)天 vs. 6.6(2-23)天;P=0.194)。

结论

IA 组和 EA 组的住院时间相似,但 IA 组的疼痛较轻,并发症较少。注册号:NCT02667860(http://www.clinicaltrials.gov)。

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