Liu Xiaoli, Nie Yusheng, Ma Qiuyue, Zhao Minxian, Li Haiyun, Guan Lei, Yang Huiqi
Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Number 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China.
Hernia. 2025 Mar 25;29(1):124. doi: 10.1007/s10029-025-03304-z.
The optimal choice of mesh material in laparoscopic hiatal hernia repair (LHHR) is debated. This study aimed to compare the short-term clinical efficacy and safety of biological versus synthetic meshes in LHHR.
In a prospective, single-center randomized controlled trial conducted from January 2020 to December 2022, 124 patients undergoing LHHR were enrolled and randomly assigned to either the biological mesh group (n = 62) or the synthetic mesh group (n = 62). The biological mesh group received non-crosslinked biological mesh, while the synthetic mesh group received polypropylene anti-adhesion mesh for hiatal closure reinforcement. Randomization was computer-generated. Baseline characteristics were collected, and patients were followed up at 6, 12, and 18 months postoperatively through telephone interviews or outpatient visits. The primary outcome was the recurrence rate of hiatal hernia, assessed by gastroscopy and upper gastrointestinal contrast radiography. Secondary outcomes included symptom improvement evaluated using the Visual Analog Scale (VAS) and the Short Form-36 (SF-36) Health Survey Questionnaire, as well as quality of life improvements. The safety of mesh was assessed by recording mesh-related complications.
Baseline characteristics were comparable between the two groups. At 18 months, the recurrence rate was 1.92% in the synthetic mesh group and 9.26% in the biological mesh group (P = 0.225). At 6 months, the biological mesh group reported significantly less early satiety compared to the synthetic mesh group (0.35 ± 1.09 vs. 0.95 ± 1.99; P = 0.046). Conversely, at 18 months, early satiety was lower in the synthetic mesh group compared to the biological mesh group (0.31 ± 1.35 vs. 1.04 ± 2.21; P = 0.043). No significant differences were observed between the groups for other symptoms or SF-36 domains at any time point (all P > 0.05). Both groups showed significant improvements in some symptoms and quality of life from preoperative to postoperative assessments (P < 0.05). No mesh-related complications were reported in either group throughout the 18-month follow-up period.
Both biological and synthetic meshes are effective and safe for use in LHHR, demonstrating similar recurrence rates and improvements in symptoms and quality of life over an 18-month period. The choice of mesh may influence early satiety at different postoperative intervals, suggesting that individualized mesh selection based on patient-specific factors may enhance postoperative outcomes.
腹腔镜食管裂孔疝修补术(LHHR)中补片材料的最佳选择存在争议。本研究旨在比较生物补片与合成补片在LHHR中的短期临床疗效和安全性。
在2020年1月至2022年12月进行的一项前瞻性、单中心随机对照试验中,纳入124例行LHHR的患者,并随机分为生物补片组(n = 62)和合成补片组(n = 62)。生物补片组使用非交联生物补片,而合成补片组使用聚丙烯防粘连补片加强食管裂孔闭合。随机分组由计算机生成。收集基线特征,并在术后6、12和18个月通过电话访谈或门诊随访患者。主要结局是食管裂孔疝的复发率,通过胃镜检查和上消化道造影评估。次要结局包括使用视觉模拟量表(VAS)和简明健康调查量表(SF - 36)评估的症状改善情况以及生活质量的改善情况。通过记录与补片相关的并发症来评估补片的安全性。
两组的基线特征具有可比性。在18个月时,合成补片组的复发率为1.92%,生物补片组为9.26%(P = 0.225)。在6个月时,生物补片组报告的早饱感明显低于合成补片组(0.35 ± 1.09 vs. 0.95 ± 1.99;P = 0.046)。相反,在18个月时,合成补片组的早饱感低于生物补片组(0.31 ± 1.35 vs. 1.04 ± 2.21;P = 0.043)。在任何时间点,两组在其他症状或SF - 36领域方面均未观察到显著差异(所有P > 0.05)。从术前评估到术后评估,两组在一些症状和生活质量方面均有显著改善(P < 0.05)。在18个月的随访期内,两组均未报告与补片相关的并发症。
生物补片和合成补片在LHHR中使用均有效且安全,在18个月期间显示出相似的复发率以及症状和生活质量的改善。补片的选择可能会影响术后不同时间段的早饱感,这表明根据患者特定因素进行个体化补片选择可能会提高术后结局。