腹腔镜全腹膜外补片植入术中补片固定与不固定的随机对照试验

A randomized controlled clinical trial comparing stapling with non-stapling of mesh in laparoscopic total extraperitoneal inguinal hernioplasty

目的 评价补片不固定的腹腔镜全腹膜外补片植入术（TEP）的安全性和有效性。方法 2004年7月至2005年12月，对60例缺损小于4cm的腹股沟疝患者进行补片不固定TEP（n-TEP）与补片固定TEP（s—TEP）的随机对照试验，随访时间12～24个月，中位时间16个月。结果 两组均无复发，各有1例血清肿，无其他并发症；n-TEP组与s—TEP组的手术时间分别为（40±10）min和（43±10）min，P=0．40，术后住院天数分别为（3．3±1．2）d和（3．7±1．5）d，P=0．275，恢复正常活动天数分别为（3．7±1．0）d和（3．9±1．4）d，P=0．596；两组在术后1、6、12个月时的补片挛缩度分别7．1％和6．4％，P=0．484、16．7％和16．6％，P=0．858、17．9％和17．1％，P=0．462；n—TEP组在术后第1天咳嗽时的疼痛分数低于s—TEP组，P=0．046，在其他时间静卧和咳嗽时的疼痛分数差异无统计学意义；n—TEP组的住院费用（6446±359）元明显低于s-TEP组（7040±943）元，差异有统计学意义（P=0．002）。结论 对于缺损小于4cm的腹股沟疝患者，n—TEP是安全有效的手术。

Objective To evaluate the clinical safety and efficiency of non-stapling of mesh in laparoscopic total extraperitoneal inguinal hernioplasty. Methods A clinical randomized control trial （RCT） was carried out in 30 non-stapling TEP （n-TEP） and 30 stapling TEP （s-TEP） from Jul 2004 to Dec 2005. Results There were no recurrence and severe postoperative morbidity in the two groups. The operating time, postoperative hospital stay and time to return to normal activity of n-TEP and s-TEP were （40±10） min vs. （43 ±10） min （P=0.,g））, （3.3±1.2） d vs. （3.7±1.5）d （P=0.275）, and （3.7 ± 1.0） d vs. （3.9 ± 1.4） d （P =0. 596） respectively. The mesh shrinkage on the first, 6^th and 12^th months postoperatively were 7.1% vs. 6.4% （P =0. 484）, 16. 7% vs. 16. 6% （P =0. 858） and 17.9% vs. 17.1% （P=0.462） in the two groups respectively. The pain score upon coughing on first day was clinically less in n-TEP than in s-TEP （P = 0. 046）, while the pain score at rest and upon coughing on the following days postoperatively showed no difference between the 2 groups. The cost in hospital of n-TEP （6446 ±359 yuan） was significantly less than s-TEP （7040 ±943 yuan） （P =0. 002）. Conclusion TEP without stapling the mesh is a safe technique for patients with a inguinal hernial defect measuring less than 4 cm.