不同聚丙烯补片在成人腹股沟疝修补术中的应用价值

Application value of different polypropylene meshes in inguinal hernia repair of adults

目的比较不同聚丙烯补片在成人腹股沟疝修补术中的应用价值。方法采用前瞻性队列研究方法。选取2012年3月至2014年3月2家医疗中心收治的120例(复旦大学附属华东医院60例、上海交通大学附属第九人民医院60例)成人腹股沟疝患者的临床资料。采用随机数字表法将患者分为研究组和对照组。研究组患者成人腹股沟疝修补术中使用SMP95958X补片,对照组患者成人腹股沟疝修补术中使用改良Kugel补片。手术由高年资疝外科专科医师行腹膜前间隙修补术。观察指标:(1)术后疼痛情况。(2)并发症和随访情况。术后3个月、6个月在门诊行体格检查或腹股沟彩色多普勒超声检查了解患者近期并发症情况;术后5年对患者进行电话或门诊随访,了解患者远期并发症(感染、异物感)及疝复发情况。随访时间截至2019年3月。正态分布的计量资料以±s表示,组间比较采用t检验;偏态分布的计量资料以M(范围)表示,组间比较采用非参数秩和检验。计数资料以绝对数和(或)百分比表示,组间比较采用χ2检验或连续矫正χ2检验或Fisher确切概率法。等级资料比较采用非参数秩和检验。结果筛选出符合研究条件的腹股沟疝患者118例;男116例,女2例;年龄为(64±12)岁,年龄范围为29~84岁。118例患者中,研究组和对照组各59例。(1)术后疼痛情况:59例对照组患者中,1例缺失术后2 d服用止痛药数据,34例术后2 d服用止痛药;59例研究组患者中29例术后2 d服用止痛药,两组患者比较,差异无统计学意义(χ^2=1.055,P>0.05)。对照组患者术后第2天、术后3个月疼痛评分分别为3.26分(0.70~6.90分)、0.87分(0.00~4.10分);研究组患者上述指标分别为3.03分(0.00~8.80分)、0.83分(0.00~3.10分),两组患者上述指标比较,差异均无统计学意义(Z=0.782,0.729,P>0.05)。(2)并发症和随访情况:对照组和研究组患者围术期(术后2 d)并发症发生率均为1.7%(1/59),两组比较,差异无统计学意义(P>0.05)。两组各有59例患者术后6个月获得随访。对照组患者术后近期(术后3个月、术后6个月)并发症发生率均为1.7%(1/59);研究组患者上述指标均为5.1%(3/59),两组患者上述指标比较,差异均无统计学意义(P>0.05)。对照组55例和研究组52例患者术后5年获得随访。对照组1例患者出现感染,术后远期(术后5年)并发症发生率为1.8%(1/55);研究组2例患者出现感染,1例患者有异物感,术后远期(术后5年)并发症发生率为5.8%(3/52),两组比较,差异无统计学意义(P>0.05)。两组患者均无疝复发。结论SMP95958X补片和改良Kugel补片均能用于腹股沟疝腹膜前间隙修补术,两者疗效比较,差异无统计学意义。

Objective To compare the application value of different polypropylene mesh in inguinal hernia repair of adults.Methods The prospective cohort study was conducted.The clinical data of 120 adult patients with inguinal hernia who were admitted to two medical centers 60 in Huadong Hospital affiliated to Fudan University and 60 in Shanghai Ninth People′s Hospital affiliated to Shanghai Jiaotong University from March 2012 to Match 2014 were collected.Patients were randomly divided into study group and control group using the random number table.Patients in the study group underwent repair of inguinal hernia using the SMP95958X mesh,and patients in the control group underwent repair of inguinal hernia using the modified Kugel mesh.All patients underwent preperitoneal repair by senior hernia surgery specialists.Observation indicators:(1)postoperative pain;(2)complications and follow-up.Patients were followed up at postoperative 3 months and 6 months using outpatient examination to detect the short-term complications by physical or color doppler ultrasonography examination,and at postoperative 5 years using telephone interview or outpatient examination to detect long-term complications including infection,foreign body sensation and recurrence of hernia.The follow-up was up to March 2019.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using the t test.Measurement data with skewed distribution were represented as M(range),comparison between groups was analyzed using the nonparametric rank sum test.Count data were described as absolute numbers or percentages,and comparison between groups was analyzed using the chi-square,continuous correction chi-square test or Fisher exact probability.Comparison of ranked data were analyzed using the nonparametric rank sum test.Results A total of 118 patients with inguinal hernia were selected for eligibility,including 116 males and 2 females,aged(64±12)years,with a range from 29 to 84 years.Of the 118 patients,59 were in the study group and 59 were in the control group,respectively.(1)Postoperative pain:of the 59 patients in the control group,34 took painkiller and 1 case lost the data of taking painkiller at postoperative 2 days.Of the 59 patients in the study group,29 cases took painkiller.There was no significant difference in taking painkiller between the two groups(χ^2=1.055,P>0.05).The pain score at postoperative 2 days and 3 months were 3.26(range,0.70-6.90)and 0.87(range,0.00-4.10)of the control group,respectively,and 3.03(range,0.00-8.80)and 0.83(range,0.00-3.10)of the study group,respectively,showing no significant difference between the two groups(Z=0.782,0.729,P>0.05).(2)Complications and follow-up:the incidence of postoperative complications at perioperative period(within postoperative 2 days)was 1.7%(1/59)and 1.7%(1/59)in the control group and study group,respectively,showing no significant difference between the two groups(P>0.05).Both of 59 patients in the control group and study group were followed up for 6 months after operation,respectively.The incidence of postoperative complications at 3 months and 6 months after operation was 1.7%(1/59)and 1.7%(1/59)in the control group,respectively,and 5.1%(3/59)and 5.1%(3/59)in the study group,showing no significant difference between the two groups(P>0.05).Fifty-five patients of the control group and 52 patients of the study group were followed up for 5 years after operation,respectively.There was 1 case of infection in the control group,with the incidence of postoperative long-term(within 5 years after operation)complication of 1.8%(1/55),and there were 2 cases of infection and 1 case of foreign body sensation in the study group with the incidence of postoperative long-term(within 5 years after operation)complication of 5.8%(3/52),showing no significant difference between the two group(P>0.05).There was no recurrence of hernia in either group.Conclusion Both of the SMP95958X mesh and the modified Kugel mesh can be used in preperitoneal repair of inguinal hernia,showing no significant difference in the efficacy between them.