生物可分解吻合环在胃肠道吻合术中应用的随机对照研究

A randomized controlled study on the application of biofragmentable anastomosis ring in gastrointestinal anastomosis

目的评价生物可分解吻合环在肠道吻合手术中的应用价值。方法按前瞻性研究方法将2004年3月至2009年2月268例预行胃肠道吻合术的病例随机分为三组，吻合环组89例，吻合器组93例，手工缝合组86例。比较其肠道功能恢复时间，吻合口相关并发症发生率。随访观察142例患者（吻合环组62例，吻合器组39例，手工缝合组41例），比较各组术后吻合口炎症发生情况。结果术后吻合口瘘：吻合环组无，吻合器组发生3例（3．2％），手工缝合组7例（8．1％）。吻合口出血：吻合环组无，吻合器组发生1例（1．1％），手工缝合组2例（2．3％），三组间差异有统计学意义（P=0．005），术后肠道功能恢复时间：吻合环组（50．0±9．0）h，吻合器组（50．3±10．0）h，手工缝合组（53．5±12．0）h，吻合环与手工缝合组问差异有统计学意义。吻合口炎症：吻合环组发生2例（3．2％），吻合器组4例（10．3％），手工缝合组15例（36．6％）。结论生物可分解吻合环术后肠道功能恢复较快，吻合口炎症发生率低，是一种安全有效，可标准化的肠道吻合方法。

Objective To evaluate the application of biofragmentable anastomosis ring in gastro - intestinal anastomosis. Methods Gastro - intestinal anastomosis was performed in 286 patients from March 2004 to February 2004. The patients were assigned randomly to anastomosis ring group （ n = 89 ） , stapling device group （ n = 93 ） and manual suture group （ n = 86 ）. The time for resumption of normal bowel functions and post - operative complications related to anastomotic site were recorded in each group. A total of 142 patients were post - operatively followed up, including 62 in anastomosis ring group, 39 in stapling device group and 41 in manual suture group. The incidence of infections at the anastomotic site was measured. Results No anastomotic leakage and bleeding occurred in the anastomosis ring group. Anastomotic leakage developed in 3 case in the stapling device group and 7 in the manual suture group. Anastomotic bleeding occurred in 1 case in the stapling device group and 2 cases in the manual suture group. Significant difference in the incidence of anastomotic leakage and bleeding was found between the anastomosis ring group,and the stapling device group as well as the manual suture group（ P = 0. 005 ）. The time for resumption to normal bowel function was（ 50.0± 9 ） h in the anastomosis ring group, （ 50.3 ± 10） h in the stapling device group and （53.5 ± 12 ）h in the manual suture group, respectively. The difference in the resumption time was statistically significant between the anastomosis ring group and the manual suture group. The anastomotic infection occurred in 2 case（3.2 % ）in the anastomosis ring group,4（ 10.3 % ）in the stapling device group and 15 （36.6%） in the manual suture group. Conclusion Use of biofragmentable anastomosis ring in gastrointestinal amastomosis helps restore the normal bowel function and reduce the anastomotic infection.