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使用电动吻合器行结直肠端端吻合术的初步临床经验。

Initial clinical experience with a powered circular stapler for colorectal anastomosis.

机构信息

University of Central Florida, College of Medicine, Orlando, FL, USA.

HCA North Florida Division, Winter Park, FL, 32792, USA.

出版信息

Tech Coloproctol. 2020 May;24(5):479-486. doi: 10.1007/s10151-020-02162-4. Epub 2020 Mar 19.

DOI:10.1007/s10151-020-02162-4
PMID:32193667
Abstract

BACKGROUND

The Echelon circular™ powered stapler (ECP stapler) obviates the need for manual firing of conventional circular staplers during the construction of a colorectal anastomosis, but has not been evaluated clinically. The aim of this study was to perform a clinical evaluation of this stapler.

METHODS

A retrospective review of the initial clinical experience of a single surgeon using the ECP stapler for left-sided colorectal anastomosis construction during elective colorectal resections for benign and malignant disease was conducted by analyzing results from a prospectively maintained study database. Additionally, four attending colorectal and/or general surgeons who had performed ≥ 5 colorectal operations with the ECP stapler were invited to complete an anonymous online survey to subjectively assess the user experience with the device. Statistical analysis was conducted using Microsoft Excel Version 15.33.

RESULTS

Seventeen patients underwent left-sided anastomotic reconstruction using the ECP stapler. All donuts (proximal and distal) were intact. Anastomotic integrity was evaluated using the air-leak test utilizing flexible video sigmoidoscopy. No leaks were observed, although one patient (5.9%) developed a postoperative pelvic abscess. The anonymous survey was completed by all four surgeons. Subjective evaluation of the ECP stapler suggests that the overall stapling quality, overall device ease-of-use, and the overall perception of anastomotic quality as above average when compared to manual 'end-to-end anastomosis' (EEA) stapling devices.

CONCLUSIONS

In an initial clinical evaluation of the ECP stapler, the safety and ease-of-use of the device appears to be satisfactory. Powered stapling and the design of '3D stapling' may provide advantages over manual systems, and may improve the construction quality of left-sided colorectal anastomosis.

摘要

背景

Echelon circular™ 电动吻合器(ECP 吻合器)免除了在构建结直肠吻合时手动击发传统圆形吻合器的需要,但尚未进行临床评估。本研究旨在对该吻合器进行临床评估。

方法

通过分析前瞻性维护的研究数据库中的结果,对一位外科医生在择期结直肠切除术中使用 ECP 吻合器进行左侧结直肠吻合构建的初始临床经验进行回顾性分析。此外,邀请四位进行了≥5 例 ECP 吻合器结直肠或普通外科手术的主治结直肠和/或普通外科医生完成匿名在线调查,以主观评估该设备的用户体验。使用 Microsoft Excel Version 15.33 进行统计分析。

结果

17 例患者接受了使用 ECP 吻合器的左侧吻合重建。所有的吻合圈(近端和远端)都是完整的。使用灵活的视频乙状结肠镜进行空气泄漏测试来评估吻合完整性。没有观察到泄漏,但有 1 例患者(5.9%)出现术后盆腔脓肿。所有四位外科医生都完成了匿名调查。与手动“端对端吻合”(EEA)吻合器相比,对 ECP 吻合器的主观评估表明总体吻合质量、总体设备易用性以及总体吻合质量感知均为中上水平。

结论

在 ECP 吻合器的初步临床评估中,该设备的安全性和易用性似乎令人满意。电动吻合和“3D 吻合”的设计可能优于手动系统,并可能改善左侧结直肠吻合的构建质量。

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