新型疝穿戴装置预防腹股沟疝修补术后早期并发症多中心真实世界研究

Multi-center real world study on the prevention of early complications after inguinal hernia repair with new hernia wearable device

目的基于真实世界数据探讨应用新型疝穿戴装置(HWD)预防腹股沟疝修补术后并发症的安全性和临床价值。方法采用前瞻性、多中心登记队列设计,纳入2022-03-01至2022-08-31全国共53家医院收治的497例行腹股沟疝修补术病人,术后均使用HWD对手术区域进行压迫。随访并分析术后血清肿发生情况和术后疼痛评分,使用卡罗莱纳舒适量表(CCS)评估生活质量,并评价HWD的使用满意度。结果497例病人中,手术方式以腹腔镜腹股沟疝修补术为主,占91.3%;修补材料以轻量聚丙烯补片为主,占84.7%;手术时间为60(49~80)min。术后1个月共有489例完成随访,随访率为98.4%。血清肿总体发生率为7.2%,腹腔镜手术病人中发生率为7.4%,开放手术病人中发生率为4.7%。在使用HWD前、使用HWD当天、术后1周和术后1个月,总体病人VAS评分分别为(2.9±1.9)分、(2.3±1.9)分、(1.5±1.6)分、(1.0±1.2)分。与使用HWD前相比,使用HWD当天病人VAS评分显著降低(P<0.001)。术后1周和术后1个月,总体病人的CCS评分均处于较低水平,分别为(28.9±21.8)、(17.2±14.4)分;术后CCS评分与疼痛程度呈正相关(r=0.903,P<0.001)。术后1周HWD总体使用满意度为95.0%。结论腹股沟疝病人术后穿戴新型HWD可以在一定程度上降低血清肿发生率,减轻术后疼痛,提高生活质量,病人使用满意度较高,建议在临床推广应用。

Objective To investigate the safety and clinical value of using new hernia wearable device(HWD)in preventing early complications after inguinal hernia repair.Methods From March 1,2022 to August 31,2022,a total of 497 patients who underwent inguinal hernia repair in 53 hospitals were prospectively enrolled in the study.All patients used HWD to compress the operative region after surgery.The incidence of seroma and postoperative pain scores were followed and analyzed.Quality of life was assessed using the Carolina Comfort Scale(CCS)and satisfaction with the use of the device was assessed.Results Of 497 patients,laparoscopic inguinal hernia repair was the main surgical method,accounting for 91.3%.Lightweight polypropylene was the main type of mesh,accounting for 84.7%.The median operating time was 60(49-80)min.Four hundred and eighty-nine cases were followed up one month after surgery,and the follow-up rate was 98.4%.The overall incidence of seroma was 7.2%,the seroma incidence after laparoscopic surgery was 7.4%,and the seroma incidence after open surgery was 4.7%.Before using HWD,on the day of using HWD,one week after surgery,and one month after surgery,overall VAS scores were(2.9±1.9),(2.3±1.9),(1.5±1.6),and(1.0±1.2),respectively.VAS scores on the day of using HWD were significantly lower than those before using HWD(P<0.001).Overall CCS scores were low one week and one month after surgery.The CCS score was positively correlated with the severity of pain(r=0.903).The overall satisfaction rate of HWD one week after surgery was 95.0%.Conclusion HWD can,to a certain degree,reduce the incidence of seroma,relieve postoperative pain,and improve the quality of life after inguinal hernia repair.User satisfaction is high.The device can be popularized and applied in clinical practice.