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

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。患者人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土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x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)人组患者情况。筛选出符合研究条件的人组患者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例均纳人符合方案集(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(χ^(2)=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)。两组患者均未发生切口感染、肠瘘、肠梗阻、肠管损伤、过敏和排异、睾丸炎和(或)菱缩以及其他并发症。结论与进口同类材质来源补片比较,国产SIS补片用于LIHR安全、有效。

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 in the protocol set(80 cases in the experimental group and 80 cases in the control group).There was no significant difference in the gender,age,body mass index(BMI),surgical method,Gilbert type of hernia,volume of intraoperative blood loss,operation time of patients between the experimental group and the control group(P>0.05),confounding bias ensured comparability.(2)Study endpoints.①Primary study endpoint.During the postoperative 6 month of follow-up,none of patient in the experimental group or the control group had hernia recurrence,with the recurrence rate as O.Results of non-inferiority test showed that the difference of hernia recurrence between the two groups was 0(95%CI as -4.58% to 4.58%),with the lower limit of -4.58% greater than the non-inferiority cut-off value of -10%,which fulfilled the noninferiority hypothesis.②Secondary study endpoints.Cases with plasmapheresis during the followup were 18 in the experimental group and 29 in the control group,respectively,showing no significant difference between the two groups(χ^(2)=3.65,P>0.05).There were 4 cases with postoperative pain and 1 case with postoperative malaise in the experimental group,and there were 8 cases with postoperative pain and O case with postoperative malaise in the control group,showing no significant difference in the above indicators between the two groups(P>0.05).None of patient in the experimental group or the control group had incision infection,enterocutaneous fistula,intestinal obstruction,intestinal canal injury,allergy and rejection,testicular inflammation and/or atrophy,or any other complication.Conclusion Compared with imported mesh of similar material origin,domestic porcine SIS mesh is safe and effective in LIHR.