生物补片与合成补片用于腹腔镜食管裂孔疝修补术短期临床疗效及安全性比较:一项多中心对照研究

Comparison of short-term clinical efficacy and safety between biological and synthetic meshesin:a multicenter controlled study

目的比较生物补片与合成补片在腹腔镜食管裂孔疝修补术中的短期临床疗效和安全性。方法前瞻性纳入2020年1月至2022年12月北京市6家医院收治的共298例行腹腔镜食管裂孔疝修补术病人,按术中应用补片类型分为生物补片组和合成补片组,各149例。术后6、12个月通过电话或门诊随访收集相关资料。结果随访12个月,生物补片组失访14例,合成补片组失访12例。生物补片组与合成补片组术后12个月的复发率差异无统计学意义[2.2%(3/135)vs.2.9%(4/137),P=0.716],且随访期间两组病人均未发生并发症。在症状改善方面,两组病人术前与术后症状评分变化(包括胸骨后烧灼感、反流、嗳气、胸痛、早饱以及吞咽困难)比较差异无统计学意义(P>0.05)。此外,两组病人在生活质量评分方面,包括术前及术后12个月的生理机能、生理功能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康及健康变化等维度,比较差异亦无统计学意义(P>0.05)。结论在腹腔镜食管裂孔疝修补术中,生物补片和合成补片在术后短期复发率、改善术后症状及提升生活质量方面具有相似效果。

Objective To compare the short-term clinical efficacy and safety of biological versus synthetic meshes in laparoscopic esophageal hiatal hernia repair.Methods This multicenter controlled clinical trial involved 298 patients undergoing laparoscopic esophageal hiatal hernia repair from January 2020 to December 2022 in six centers,led by Beijing Chaoyang Hospital,Capital Medical University.Participants were divided into either the biological mesh group or the synthetic mesh group,with 149 patients in each.Follow-up data were collected at 6 and 12 months postoperatively via phone or clinic visits.Results No significant difference was observed in the recurrence rates at 12 months postoperatively between the two groups,with 2.2%(3/135)in the biological mesh group and 2.9%(4/137)in the synthetic mesh group(P=0.716).Additionally,no complications were observed during the follow-up period in either group.Regarding symptom improvement,preoperative symptom scores comparison showed no significant differences between the biological and synthetic patch groups in terms of burning sensation behind the sternum,acid reflux,belching,chest pain,early satiety,,and dysphagia(P>0.05).Similarly,there was no significant difference in symptom improvement scores at 12 months post-surgery between the two groups(P>0.05).Furthermore,comparisons of quality of life scores,including physical functioning,role physical,bodily pain,general health,vitality,social functioning,role emotional,mental health,and health change,before and 12 months after surgery,revealed no significant differences between the groups(P>0.05).Conclusion In laparoscopic hiatal hernia repair,biological and synthetic meshes exhibit similar short-term recurrence rates,symptom improvement,and quality of life enhancements.