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腹腔镜右半结肠切除术中体外与体内回结肠吻合器吻合术:一项随机临床试验的中期分析

Extracorporeal vs. Intracorporeal Ileocolic Stapled Anastomoses in Laparoscopic Right Colectomy: An Interim Analysis of a Randomized Clinical Trial.

作者信息

Vignali Andrea, Bissolati Massimiliano, De Nardi Paola, Di Palo Saverio, Staudacher Carlo

机构信息

Department of Surgery, IRCCS San Raffaele, University Vita e Salute , Milan, Italy .

出版信息

J Laparoendosc Adv Surg Tech A. 2016 May;26(5):343-8. doi: 10.1089/lap.2015.0547. Epub 2016 Feb 26.

Abstract

AIM

The role of intracorporeal anastomosis (IA) in right colectomy is still controversial. Primary endpoint of the present study is to evaluate the impact of IA versus extracorporeal anastomosis (EA) on recovery of bowel function and length of stay in right colon cancer patients.

MATERIALS AND METHODS

Adult patients with histologically proven cancer of the right colon were randomized to laparoscopic right colectomy with IA or EA anastomosis. Admitting a two-sided type I error level of 0.01 and an estimated power of 80%, 79 patients for each group were needed to test the primary endpoint.

RESULTS

At the time of this interim analysis, 60 patients were randomized; 30 were assigned to the IA group and 30 to the EA group. The two groups were homogeneous with respect to demographics, American Surgical Association score, and tumor stage. In the IA group, a longer operating time (P = .04), an earlier recovery of bowel function (P = .048), and a lower incidence of postoperative ileus (P = .05) were observed. No differences were observed between the two groups with respect to length of stay (P = .70) and complication rate (P = .89). Anastomotic leak rate occurred in two patients in the IA group, while no leak occurred in EA.

CONCLUSIONS

Intracorporeal anastomosis could be considered a valuable option in the hands of expert surgeons, with favorable effect on recovery of bowel function and postoperative ileus. Definitive answers on its safety and efficacy will be given once the present randomized controlled trial (RCT) will be complete.

摘要

目的

体内吻合术(IA)在右半结肠切除术中的作用仍存在争议。本研究的主要终点是评估IA与体外吻合术(EA)对右半结肠癌患者肠功能恢复和住院时间的影响。

材料与方法

经组织学证实为右半结肠癌的成年患者被随机分为接受IA或EA吻合术的腹腔镜右半结肠切除术组。设定双侧I型错误水平为0.01,估计检验效能为80%,每组需要79例患者来检验主要终点。

结果

在本次中期分析时,60例患者被随机分组;30例被分配到IA组,30例被分配到EA组。两组在人口统计学、美国外科协会评分和肿瘤分期方面具有同质性。在IA组中,观察到手术时间更长(P = 0.04)、肠功能恢复更早(P = 0.048)以及术后肠梗阻发生率更低(P = 0.05)。两组在住院时间(P = 0.70)和并发症发生率(P = 0.89)方面未观察到差异。IA组有2例患者发生吻合口漏,而EA组未发生漏。

结论

在经验丰富的外科医生手中,体内吻合术可被视为一种有价值的选择,对肠功能恢复和术后肠梗阻有良好效果。一旦当前的随机对照试验(RCT)完成,将给出关于其安全性和有效性的确切答案。

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