复合基底膜生物补片应用于腹股沟疝Lichtenstein修补术的随机、对照、多中心临床研究  

Evaluation of the composite basement membrane biological mesh in Lichtenstein inguinal hernia repair:a multicenter,RCT clinical study

作　　者：李绍杰[1] 谢奇峰 李绍春 杨子昂[3] 黄永刚[4] 陈吉彩[5] 杜舟[5] 王平[4] 张剑 唐健雄[1] Shaojie Li;Qifeng Xie;Shaochun Li;Ziang Yang;Yonggang Huang;Jicai Chen;Zhou Du;Ping Wang;Jian Zhang;Jianxiong Tang(Department of General Surgery,Huadong Hospital Affiliated to Fudan University,Shanghai 200040;China2.Department of Anorectal Surgery,the Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital),Shanghai 200003;China3.Department of General Surgery,Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032;Department of Hernia and Abdominal Wall Surgery,Affiliated Hangzhou First People's Hospital,Hangzhou 310006;Department of Hernia and Abdominal Wall Surgery,the First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325015)

机构地区：[1]复旦大学附属华东医院普通外科,上海200040 [2]海军军医大学第二附属医院(上海长征医院)肛肠外科,上海200003 [3]复旦大学附属中山医院普通外科,上海200032 [4]杭州市第一人民医院疝和腹壁外科,310006 [5]温州医科大学第一附属医院疝和腹壁外科,浙江325015

出　　处：《中华疝和腹壁外科杂志（电子版）》2024年第2期132-138,共7页Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition)

基　　金：国防科技卓越青年科学基金(2019-JCJQ-ZQ-002);国家药监局药品监管科学研究重点项目(RS2024X004)。

摘　　要：目的比较一款复合基底膜生物补片与猪小肠黏膜下层(SIS)补片在开放无张力腹股沟疝修补术中的临床效果。方法自2019年1月至2020年1月,在复旦大学附属华东医院、海军军医大学第二附属医院(上海长征医院)、复旦大学附属中山医院、杭州市第一人民医院和温州医科大学附属第一医院,5个中心招募单侧原发性腹股沟疝并自愿接受开放式无张力疝修补术的患者,进行随机、单盲、平行对照、多中心试验。将符合入组标准、不符合排除标准的腹股沟疝患者按照1∶1的比例分为试验组和对照组,试验组使用复合基底膜生物补片、对照组使用SIS补片,按照Lichtenstein术式进行腹股沟疝无张力疝修补术。观察患者术后180d的无疝复发率、并发症发生率,并完成术后4年的长期随访。结果在1年研究期间,5个中心共招募140名患者,有2例试验组患者脱落,最终138例患者纳入研究,其中试验组患者68例,对照组70例。试验组的体重较对照组更轻(P=0.028),体重指数更低(P=0.035),差异有统计学意义(P<0.05),2组的其他基础资料比较差异均无统计学意义。试验组手术时间较对照组更短(P=0.035),在运动视觉模拟评分(VAS)中,试验组较对照组评分更低,且2组差异有统计学意义(F_(组间)=6.165,P_(组间)=0.014),同时在不同时间点上均低于对照组,差异有统计学意义(F时间=168.4,P时间<0.0001),2组的时间与运动VAS评分交互上差异有统计学意义(F_(交互)=2.921,P_(交互)=0.034)。试验组血清肿发生率(4.62%)显著低于对照组(15.39%),差异有统计学意义(P=0.047),术后180 d试验组无疝复发,对照组1例复发,2组无疝复发率比较差异无统计学意义(P>0.05)。非劣效检验结果显示:2组患者疝复发率之差为-1.39%[95%CI(-6.23%~3.45%)],可信区间上限<10%。后续4年随访中,试验组58例患者无疝复发,对照组54例患者有4例疝复发,其中2例已再次治疗,2组无疝复发Objective To investigate the clinical efficacy of a composite basement membrane biological mesh compared to the small intestine submucosa(SIS)mesh for open tension-free inguinal hernia repair.Methods From January 2019 to January 2020,a randomized,single-blind,parallel-controlled,multicenter trial was conducted at five centers:Huadong Hospital Affiliated to Fudan University,Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital),Zhongshan Hospital Affiliated to Fudan University,First People's Hospital of Hangzhou City,and First Affiliated Hospital of Wenzhou Medical University.Patients with unilateral primary inguinal hernia who voluntarily underwent open tension-free hernia repair were recruited.Patients with inguinal hernia who met the inclusion criteria but did not meet the exclusion criteria were randomly divided into experimental group and control group according to the ratio of 1:1.The experimental group received composite basement membran biological mesh while the control group received the SIS mesh.Both groups underwent tension-free inguinal hernia repair following Lichtenstein's technique.The recurrence rate and complication rate were observed in the patients 180 days after surgery,and long-term follow-up was completed for 4 years postoperatively.Results During the one-year study period,a total of 140 patients were recruited from the five centers,and 2 patients in the experimental group dropped out during the study period.Finally,138 patients were included in the study,with 68 cases in the experimental group and 70 cases in the control group.The experimental group had lower body weight and body mass index compared to the control group,showing statistical significance(P=0.028,0.035).There were no statistically significant differences in terms of other baseline characteristics between the two groups.The operative time in the experimental group was shorter than that in the control group(P=0.035).In terms of movement Visual Analog Scale(VAS)scores,the experimental group had lower

关 键 词：补片 基底膜 猪小肠黏膜下层 疝 腹股沟 疝修补术 

分 类 号：R656.21[医药卫生—外科学]