新型生物补片在腹腔镜腹股沟疝修补术中临床价值的多中心前瞻性随机对照研究  

Clinical value of a novel biological mesh in laparoscopic inguinal hernia repair: a multicenterprospective randomized controlled study

作　　者：薛佩[1] 李绍杰[2] 乐飞[1] 程文悦 冯波[1] 李健文[1] 张剑 唐健雄[2] Xue Pei;Li Shaojie;Yue Fei;Cheng Wenyue;Feng Bo;Li Jianwen;Zhang Jian;Tang Jianxiong(Department of General Surgery,Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Shanghai Minimal Invasive Surgery Center,Shanghai 200025,China;Department of General Surgery,Huadong Hospital Affiliated to Fudan University,Shanghai 200040,China;Department of Anorectal Surgery,the Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital),Shanghai 200003,China)

机构地区：[1]上海交通大学医学院附属瑞金医院普通外科,上海市微创外科临床医学中心,上海200025 [2]复旦大学附属华东医院普通外科,上海200040 [3]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

出　　处：《中华消化外科杂志》2023年第4期532-540,共9页Chinese Journal of Digestive Surgery

基　　金：国防科技卓越青年科学基金(2019‑JCJQ‑ZQ‑002);国防科技基础加强计划(2019‑JCJQJJ‑069)。

摘　　要：目的:探讨新型非交联生物补片在腹腔镜腹股沟疝修补术中的临床价值。方法:采用前瞻性随机对照研究方法。选取2019年9月至2020年3月上海交通大学医学院附属瑞金医院等3家医学中心收治的50例成人单侧腹股沟疝患者的临床资料,按照随机数字表法将患者分为两组。患者修补术中使用新型非交联生物补片设为试验组;修补术中使用轻质大网孔部分可吸收合成补片设为对照组。观察指标:(1)入组患者分组情况。(2)研究终点。正态分布的计量资料以x±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χ^(2)检验或Fisher确切概率法。等级资料比较采用非参数秩和检验。重复测量数据采用重复测量方差分析。以疝复发率作为有效性评价依据,按照意向性治疗分析,使用可信区间法(Newcombe Wilson法)对两组的疝复发率进行非劣效统计分析,如果两组疝复发率之差的95%可信区间上限<10%,则认为试验组非劣于对照组。结果:(1)入组患者分组情况。筛选出符合研究条件的成人腹股沟疝患者50例;男44例,女6例;年龄为(60±15)岁。50例患者随机分配至试验组和对照组各25例。对照组1例患者未进行术后2个月的随访,其余均完成所有预期随访。两组患者均无脱落、剔除。(2)研究终点。①主要研究终点:试验组和对照组患者疝复发率分别为0和4%(1/25),两组比较,差异无统计学意义(P>0.05)。非劣效检验结果显示:两组患者疝复发率之差的95%可信区间为-19.54%~9.72%,可信区间上限9.72%<10%。②次要研究终点:对照组2例患者术后14 d发生血清肿,两组其余患者随访期间均无血清肿发生,两组比较,差异无统计学意义(P>0.05)。对照组1例患者术后2个月主诉存在腹股沟区不适或异物感,两组其余患者随访期间均无腹股�Objectives To investigate the clinical value of a novel non-crosslinked biological mesh in laparoscopic inguinal hernia repair.Methods The prospective randomized controlled study was conducted.The clinical data of 50 adult patients with unilateral inguinal hernia who were admitted to 3 medical centers,including Ruijin Hospital of Shanghai Jiaotong University School of Medicine et al,from September 2019 to March 2020 were selected.Based on random number table,patients were divided into two groups.Patients using the novel non-crosslinked biological mesh in repair surgery were divided into the experiment group and patients using the lightweight,microporous,partially absorbable synthetic mesh in repair surgery were divided into the control group.Observation indicators:(1)grouping situations of the enrolled patients;(2)endpoint of the study.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was conducted using the t test.Measurement data with skewed distribution were represented as M(range),and comparison between groups was conducted using the non-parameter rank sum test.Count data were described as absolute numbers and(or)persentages,and comparison between groups was conducted using the chi-square test or Fisher exact probability.Comparison of ordinal data was conducted using the non-parameter rank sum test.Repeated measurement data were analyzed using the repeated ANOVA.Taking the recurrence rate of hernia as the basis of efficacy evaluation,according to the intention-to-treat analysis,the confidence interval method(Newcombe Wilson method)was used to conduct non-inferiority statistical analysis of the recurrence rate of hernia between the experiment group and the control group.If the upper limit of 95%confidence interval of the difference of recurrence rate of hernia between the experiment group and the control group is less than 10%,the experiment group is considered to be non-inferior to the control group.Results(1)Grouping situations of the enrolled patients.A tot

关 键 词：疝 腹股沟 生物补片 合成补片 腹腔镜检查 

分 类 号：R656.21[医药卫生—外科学]