Kracht M, Hay J M, Fagniez P L, Fingerhut A
French Association for Surgical Research, Bois-Colombes.
Int J Colorectal Dis. 1993 Mar;8(1):29-33. doi: 10.1007/BF00341273.
440 patients were prospectively enrolled in a randomized, multicenter trial to compare 4 types of manual (84 interrupted end-to-end, 77 continuous end-to-end, 82 interrupted end-to-side, and 91 continuous end-to-side) (polyglycolic derived suture) and 1 type of stapled (106 side-to-side with GIA+TA devices) ileocolonic anastomosis after right hemicolectomy for carcinoma. The trial was designed according to Schwartz' pragmatic formulation. All 5 groups were well-matched, except for a lower rate of intraoperative sepsis in the stapled group (P < 0.02). The main end point was anastomotic leakage detected clinically or by routine sodium diatrizoate enema on the 8-10th postoperative day. Results showed that stapled ileocolonic anastomosis was associated with less anastomotic leakages (2.8%) than all the other techniques combined (8.3%). In spite of the fact that staples are approximately ten times more expensive, our results suggest performing side-to-side (GIA+TA) mechanical anastomosis after right resection for carcinoma.
440例患者前瞻性纳入一项随机多中心试验,比较4种手工(84例间断端端吻合、77例连续端端吻合、82例间断端侧吻合和91例连续端侧吻合)(聚乙醇酸缝线)和1种吻合器(106例使用GIA+TA器械行侧侧吻合)在结肠癌右半结肠切除术后行回结肠吻合术的效果。该试验按照施瓦茨的实用方案设计。除吻合器组术中脓毒症发生率较低外(P<0.02),所有5组匹配良好。主要终点是术后第8至10天临床检测或通过常规泛影葡胺灌肠检测到的吻合口漏。结果显示,吻合器回结肠吻合术的吻合口漏发生率(2.8%)低于其他所有技术的总和(8.3%)。尽管吻合器的费用大约高10倍,但我们的结果提示,结肠癌右半结肠切除术后应行侧侧(GIA+TA)机械吻合术。