生物可分解吻合环与手工缝合在肠吻合术中的随机对照研究

A randomized controlled study on the application of the biofragmentable anastomosis ring and manual suture in intestinal anastomosis

目的评估生物可分解吻合环在肠道吻合手术中的应用。方法将需行肠吻合术的患者随机分成两组:吻合环组9 2例,手工缝合组9 4例,共1 8 6例。术后分别记录与吻合口有关的并发症、肠功能恢复时间等情况。1 2 7例结肠肿瘤患者(吻合环组6 2例,手工缝合组6 5例)术后随访时观察吻合口炎症发生的情况。两组病例一般资料分布均衡。结果2例(2.1 7%)患者术中出现使用吻合环困难。两组各死亡1例,但均与手术操作无关。术后肠功能恢复时间:吻合环组(6 1.4±8.6)h,手工缝合组(6 8.3±9.7)h,两组之间差异无显著性(P>0.0 5)。吻合环组发生术后吻合瘘1例(1.1%),手工缝合组发生2例(2.1%)(P>0.05);吻合环组发生术后吻合口出血2例(2.2%),手工组缝合组发生1例(1.1%)(P>0.0 5);两组术后均未发生吻合口梗阻;吻合环组发生吻合口炎症2例(3.2%),手工缝合组发生1 3例(2 0.0%),两组之间差异有显著性(P<0.01)。结论生物可分解吻合环是一种安全有效的肠吻合装置。

Objective To assess the application of the biofragmentable anastomosis ring （BAR） in intestinal anastomosis. Methods One hundred and eighty-six patients who undergoing intestinal anastomosis were randomly allocated to biofragmentable anastomosis ring group （ BAR group, n = 92 ） and manual suture group （ control group n = 94 ） , The restoration time of bowel fanctions, and the post-operative complications related to anastomotic site were recorded in each group. One hundred tweenty-seven patients with colonic carcinoma （62 patients in BAR group and 65 patients in manual group ） were followed up post-operatively, and the incidence of inflammatory reactions at the anastomotic site was registered. Results In 2 patients （ 2. 17 % ） it was difficult to use the BAR procedure. One mortality was recorded in each group, but were not related to anastomotic procedure. In BAR group and manual group, post-operative bowel restoration time was 61.4 ± 8.6h and 68.3 ± 9.7h respectively（ P 〉 0.05 ） . In BAR group and manual group, anastomotic leaks, anastomotic bleeding and obstruction occurred in 1 , 2 ; 2,1 and 0,0 patients respectively （ all P 〉 0.05 ） . Anastomotic inflammatory reaction occurred in 2 patients （ 3.2 % ） in BAR group and 13 patients （ 20.0 % ） in manual group. The difference was statistically significant （P 〈 0. 01 ）. Conclusions BAR is a safe and effective device for intestinal anastomsis.