Chandramohan S M, Gajbhiye Raj Narenda, Agwarwal Anil, Creedon Erin, Schwiers Michael L, Waggoner Jason R, Tatla Daljit
Department of Surgical Gastroenterology, Government General Hospital, Chennai, 600003 India.
Department of Surgery, Indira Gandhi Government Medical College, Nagpur, 440018 India.
Indian J Surg. 2013 Aug;75(4):311-6. doi: 10.1007/s12262-012-0496-6. Epub 2012 Apr 26.
Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.
尽管在胃肠手术中，吻合器吻合是手工缝合的一种替代方法，但目前缺乏专门设计用于评估两者在手术时间、吻合时间和肠道功能恢复方面差异的试验。本试验比较了接受开放性胃肠手术患者中这两种方法的效果。将接受急诊或择期手术且需要进行单处胃、小肠或大肠吻合的成年患者纳入这项开放标签、前瞻性、随机、干预性、平行、多中心对照试验。手工缝合组（n = 138）和吻合器吻合组（n = 142）按1:1比例随机分组。收集并比较吻合时间、手术时间和肠道功能恢复时间作为主要终点指标。2009年4月至2010年9月共纳入280例患者。两组之间仅吻合时间有显著差异：吻合器吻合组为17.6±1.90分钟，手工缝合组为20.6±1.90分钟。这种差异在临床或经济方面被认为无意义。两组的安全性指标和其他次要终点指标相似。在构建胃肠吻合口方面，机械吻合器吻合比手工缝合更快。除此之外，在本试验所测量的结果方面，吻合器吻合和手工缝合相似。
