猪小肠黏膜下层脱细胞基质补片在腹腔镜腹股沟疝修补术中应用价值的多中心前瞻性随机对照研究  

Application value of porcine small intestinal submucosa acellular matrix mesh in laparoscopic inguinal hernia repair:a multicenter prospective randomized controlled study

作　　者：靳翠红 曹金鑫[1] 吴立胜 吕忠船[3] 魏光兵[4] 姚晨[5] 申英末[1] 陈杰[6] Jin Cuihong;Cao Jinxin;Wu Lisheng;Lyu Zhongchuan;Wei Guangbing;Yao Chen;Shen Yingmo;Chen Jie(Department of Hernia and Abdominal Wall Surgery,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100043,China;Department of Hernia and Obesity Surgery,The First Affiliated Hospital of University of Science and Technology of China,Hefei 230001,China;Department of General Surgery,Yantai Yuhuangding Hospital,Yantai 264008,China;Department of General Surgery,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China,Department of Statistics,Peking University First Hospital,Beijing 100034,China;Department of Hernia and Abdominal Wall Surgery,Peking University People's Hospital,Beijing 100044,China)

机构地区：[1]首都医科大学附属北京朝阳医院疝和腹壁外科,北京100043 [2]中国科学技术大学附属第一医院疝及肥胖外科,合肥230001 [3]烟台毓璜顶医院普通外科,烟台264008 [4]西安交通大学第一附属医院普通外科,西安710061 [5]北京大学第一医院医学统计室,北京100034 [6]北京大学人民医院疝和腹壁外科,北京100044

出　　处：《中华消化外科杂志》2024年第9期1188-1194,共7页Chinese Journal of Digestive Surgery

基　　金：吴阶平医学基金会临床科研专项(320.6750.2021-07-1)。

摘　　要：目的探讨猪小肠黏膜下层脱细胞基质(SIS)补片在腹腔镜腹股沟疝修补术(LIHR)中的应用价值。方法采用前瞻性、多中心、随机对照、单盲、非劣效性研究方法。选取2021年4月至2022年8月首都医科大学附属北京朝阳医院等全国4家医学中心收治的216例行LIHR患者的临床资料, 使用中央随机系统将患者分为两组:试验组使用国产SIS补片, 对照组使用进口同类材质来源补片。患者入组情况基线特征评价使用全分析集, 有效性指标评价使用符合方案集。正态分布的计量资料以xˉ±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Wilcoxon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Fisher确切概率法。试验组与对照组有效率差值的95%可信区间(CI)下限>非劣效界值?10%, 则试验组与对照组相比为非劣效。结果 (1)入组患者情况。筛选出符合研究条件的入组患者216例, 因不依从试验方案脱落46例, 其余170例纳入全分析集;因失访脱落9例, 完成随访161例, 试验组1例不符合纳入标准被剔除, 其余160例均纳入符合方案集(试验组80例, 对照组80例)。两组患者性别、年龄、体质量指数、手术方式、Gilbert疝分型、出血量、手术时间比较, 差异均无统计学意义(P>0.05), 具有可比性。(2)研究终点。①主要研究终点:术后随访6个月, 试验组和对照组患者均无疝复发, 复发率为0。非劣效检验结果显示:两组患者疝复发率差值为0(95%CI为-4.58%~4.58%), 下限为-4.58%>?10%, 满足非劣效假设。②次要研究终点:随访期内试验组和对照组患者分别有18例和29例发生浆液肿, 两组比较, 差异无统计学意义(χ2=3.65, P>0.05)。试验组患者中术后疼痛4例、术后不适感1例;对照组患者中术后疼痛8例, 无术后不适感。两组患者上述指标比较, 差异均无统计学意义(P>0.05)。两组患Objective To investigate the application value of porcine small intestinal submucosa(SIS)acellular matrix mesh in laparoscopic inguinal hernia repair(LIHR).MethodssThe prospective multicenter randomized controlled single-blind non-inferiority-type study was conducted.The clinical data of 216 patients who underwent LIHR in 4 medical centers,including Beijing Chaoyang Hospital of Capital Medical University et al,from April 2021 to August 2022 were selected.Patients were divided into two groups using a central randomization system.Patients in the experimental group were implanted domestic SIS mesh,and patients in the control group were implanted imported mesh of similar material origin.The baseline characteristics of enrolled patients were evaluated using the full analysis set,and the effectiveness indicators were evaluated using the protocol set.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 Wilcoxon rank sum test.Count data were expressed as absolute numbers and/or percentages,and comparison between groups was conducted using the chi-square test or Fisher exact probability.If the lower limit of 95% confidence interval(CI)of the difference in effective rates between the experimental group and the control group was greater than the non-inferiority cut-off value of -10%,the experimental group was considered non-inferior to the control group.Results(1)Situations of the enrolled patients.A total of 216 patients were selected for eligibility,with 46 patients dropping out due to violation of the trial protocol,and the remaining 170 patients were included in the full analysis set.Nine patients were dislodged due to loss to follow-up,and 161 patients completed follow-up.One case in the experimental group was excluded due to violating the inclusion and exclusion criteria,while the remaining 160 patients were included

关 键 词：疝 腹股沟 生物补片 猪小肠黏膜下层 随机对照研究 临床疗效 

分 类 号：R656.21[医药卫生—外科学]