腹腔镜疝修补术与开放式疝修补术的真实世界研究

Laparoscopic hernia repair and open hernia repair in the real world

目的通过真实世界数据,评价不同疝修补术(腹腔镜手术与开放式手术)、腔镜下不同类型补片(三维立体预成形补片与自固定补片)治疗腹股沟疝的有效性、安全性和经济性。方法采用多中心、回顾性、真实世界研究的设计方法,收集2016年3月至2019年3月就诊于浙江省3家三甲医院的腹股沟疝患者的临床数据。以手术时间和住院天数作为有效性指标;以术中出血量和术后并发症发生情况(止疼药处方比例、抗感染药物处方比例)作为安全性指标;以直接医疗成本作为经济性评价指标,评价使用不同术式(腹腔镜修补术与开放式修补术)、不同类型补片(三维立体预成形补片与自固定补片)的腹股沟疝患者在有效性、安全性和经济性方面的差异。结果1)不同术式比较:腹腔镜组手术时间长于开放式组,住院天数短于开放式组,差异有统计学意义(P<0.05);腹腔镜组术后使用止疼药患者比例高于开放式组,差异有统计学意义(P<0.05);而相较于开放式组,腹腔镜组术后使用抗感染药物患者比例更低,差异有统计学意义(P<0.05);腹腔镜组比开放式组总费用更高(P<0.05),主要是由于手术费和材料费均较高(P<0.05)。2)不同类型补片比较:两组手术时间和住院天数比较差异均无统计学意义(P>0.05);三维立体预成形补片组使用止疼药患者比例、抗感染药物患者比例均低于自固定补片组,差异有统计学意义(P<0.05);三维立体预成形补片组总费用低于自固定补片组,差异有统计学意义(P<0.05),对费用组成结构进行分析,发现与自固定补片组相比,三维立体预成形补片组的材料费、补片费用、总药品费用、术后使用止疼与抗感染药品费用均较低(P<0.05)。结论腹腔镜手术比开放式手术具有更优的有效性和安全性,但总费用更高。另外,使用三维立体预成形补片进行腹腔镜手术与使用自固定补片相比,平均总花费较低,且安全性更好。

Objective To evaluate the effectiveness,safety and economy of different kinds of inguinal hernia repair surgery(laparoscopic vs.open surgery)and different types of mesh(three-dimensional(3D)preformed mesh vs.self-fixation mesh)fixation for laparoscopic repair of inguinal hernia based on real-world data.Methods A multicenter,retrospective,real-world study was designed to collect clinical data of inguinal hernia patients admitted to 3 top III hospitals in Zhejiang Province from March 2016 to March 2019.The time of operation and the length of hospital stay were taken as the effectiveness index.Intraoperative blood loss and postoperative complications(proportion of prescription of painkillers and proportion of prescription of anti-infective drugs)were used as safety indexes.Direct medical cost is used as the economic evaluation index.Based on real-world data and evaluation indicators,a retrospective study was conducted to evaluate the effectiveness,safety and economy of inguinal hernia patients using different surgical methods(laparoscopic repair versus open repair)and different types of mesh(three-dimensional preformed patch versus self-fixed patch).Results 1)Comparison of different operation methods:the operation time of laparoscopic group was longer than that of open group,and the length of hospital stay was shorter than that of open group,with statistical significance(P<0.05);The proportion of patients using painkillers after surgery in laparoscopic group was higher than that in open group,and the difference was statistically significant(P<0.05).Compared with the open group,the proportion of patients using anti-infective drugs after surgery in the laparoscopic group was lower,and the difference was statistically significant(P<0.05).The total cost was higher in the laparoscopic group than in the open group(P<0.05),mainly due to the higher operation cost and material cost(P<0.05).2)Comparison of different types of mesh:There was no statistical significance in operation time and hospital stay between the two groups(P>0.05);The proportion of patients using painkillers and anti-infective drugs in 3D preformed patch group was lower than that in self-fixed patch group,and the difference was statistically significant(P<0.05).The total cost of the three-dimensional preformed patch group was lower than that of the self-fixed patch group,with statistical significance(P<0.05).The analysis of the cost composition showed that compared with the self-fixed patch group,the cost of materials,patch,total drug,postoperative pain relief and anti-infection drugs were lower in the three-dimensional preformed patch group(P<0.05).Conclusion Compared with open surgery,laparoscopic surgery has better efficacy and safety with higher total cost.The analysis of the two mesh types commonly used in laparoscopic surgery showed that the three-dimensional preformed mesh had advantages of lower cost and better safety than the self-fixation mesh.