Department of Colorectal Surgery, Pôle des Maladies de l'Appareil Digestif, Beaujon Hospital, AP-HP, Clichy, France.
Colorectal Dis. 2011 Jun;13(6):711-5. doi: 10.1111/j.1463-1318.2010.02246.x. Epub 2010 Feb 20.
The purpose of this study was to assess the safety and effectiveness of a new cost-effective circular stapler for colorectal anastomosis, the Chex(®) CS.
From 2007 to 2009, a case-control study was conducted of 54 patients who underwent left colectomy with stapled anastomosis using the Chex stapler. The patients were matched to 64 patients in whom the anastomoses were performed using the CDH(®) stapler or the EEA(®) stapler. The following criteria were matched: sex, age, body mass index, American Society of Anesthesiology grade, diagnosis, formation of a temporary stoma and surgical approach. Primary end-points were postoperative mortality and morbidity. The surgeon was asked to fill out a questionnaire to assess the ergonomics of the device using an analogue visual scale. A cost analysis was performed to compare the cost of the different devices.
There were no postoperative deaths. Morbidity, including anastomotic leakage (9%vs 8%, P = 1.000), was similar in the two groups. The surgeon's overall appreciation was scored at 8.1/10 (3-9.5), including the best score for stapler removal (9.5). No major device failure was observed during the study. Mean surgical costs were significantly lower in the Chex group: € 903 ± 73 (885-1192) vs the control group € 971 ± 61 (956-1263) (P < 0.0001).
This study suggests that colorectal anastomosis using the Chex circular stapler is safe and does not increase overall morbidity. In particular, this device did not have a higher rate of anastomotic leakage in our patients than more expensive models currently used in our hospital.
本研究旨在评估新型经济有效的 Chex（®） CS 圆形吻合器在结直肠吻合中的安全性和有效性。
2007 年至 2009 年，我们对 54 例行左结肠切除术并使用 Chex 吻合器进行吻合的患者进行了病例对照研究。将这些患者与使用 CDH（®）吻合器或 EEA（®）吻合器进行吻合的 64 例患者进行匹配。匹配的标准包括：性别、年龄、体重指数、美国麻醉医师协会（ASA）分级、诊断、临时造口的形成和手术途径。主要终点为术后死亡率和发病率。术者被要求使用模拟视觉量表填写一份评估器械人机工程学的问卷。进行成本分析以比较不同器械的成本。
无术后死亡。两组的发病率，包括吻合口漏（9%vs 8%，P = 1.000），相似。术者的总体评价评分为 8.1/10（3-9.5），其中吻合器移除的评分最高（9.5）。在研究期间未观察到主要器械故障。Chex 组的平均手术费用明显较低：903 ± 73 欧元（885-1192）vs 对照组 971 ± 61 欧元（956-1263）（P < 0.0001）。
本研究表明，使用 Chex 圆形吻合器进行结直肠吻合是安全的，不会增加总体发病率。特别是，与我们医院目前使用的更昂贵的模型相比，该器械在我们的患者中没有更高的吻合口漏发生率。
