国产新型防粘连复合补片与进口同类产品在腹外疝腹腔内修补术中的对比研究

目的：对比应用国产善释防粘连复合疝修补片与同类进口产品在腹外疝及腹壁缺损患者中行腹腔内的修补手术，探讨善释防粘连复合补片在腹外疝及腹壁缺损治疗中的应用价值。方法采用前瞻性随机分组对照研究，将符合条件的患者分为二组，试验组使用善释防粘连复合补片，对照组使用进口同类补片，每组各25例患者。记录二组患者手术前后的临床参数及术后各种并发症的发生例数，通过超声检查，记录术后7d及术后3个月补片下内脏移动距离，对疝修补片的防粘连性能做出客观评估，并对数据进行统计学分析。结果对二组的近期疗效、手术前后临床参数和术后并发症发生情况等方面进行统计学对比分析，二组患者在手术时间、术后住院日数、近期疗效、手术前后临床参数、术后补片下内脏移动距离和术后并发症发生情况等方面差异均无统计学意义。结论善释防粘连复合补片是一种安全、可靠的腹外疝及腹壁缺损腹腔内修补的国产新型材料。

Comparative study of a new domestic anti-adhesive mesh and imported similar product in intraperitoneal repair of abdominal hernia

Objective To compare a new type of domestic anti-adhesive mesh （ShanShi, TransEasy）with the imported similar product （PCO,Covidien）used in hernioplasty of ventral hernia and abdominal wall defects,and to further evaluate the application of ShanShi anti-adhesive mesh in clinical practice.Methods A prospective randomized control study was conducted.Patients met the inclusion criteria were randomly assigned to two groups （25 cases in each group）：ShanShi anti-adhesive mesh was used in test group,PCO mesh served as control.Perioperative clinical data and postoperative complications were recorded.With the help of ultrasound examination at 7day and 3 months after operation,visceral migration below the mesh was detected and recorded. Anti-adhesive properties of both meshes were objectively assessed,and the data was statistically analyzed.Results Short-term outcome,clinical data before and after operation,and postoperative complications were compared statistically in both of the two groups.There were no significant differences with regard to operating time,length of postoperative stay, short-term outcome,perioperative clinical parameters,distance of visceral migration and postoperative complications between the groups involved.Conclusion ShanShi anti-adhesive composite mesh which is a new type of domestic material,have been shown to be a safe and effective mesh for intraperitoneal repair of ventral hernia and abdominal wall defects.