新型立体小肠黏膜下层补片在猪食管裂孔疝修补中的可行性研究

Feasibility study of a novel three-dimensional small intestinal submucosa patch in porcine hiatal hernia repair

摘要:

背景与目的 腹腔镜下食管裂孔疝修补术（LHHR）虽为治疗食管裂孔疝（HH）的金标准，但因裂孔扩大及膈食管韧带破坏，术后复发率仍较高。本研究设计新型立体小肠黏膜下层（SIS）补片，旨在实现膈肌环周加固与膈食管韧带重建，评价其在猪LHHR模型中的可行性、安全性及短期修复效果。方法 选用12头健康三元猪（35~40 kg），随机均分为无补片组、SIS平片组和立体SIS补片组，均在全麻下行LHHR及Nissen胃底折叠术。无补片组仅间断缝合关闭裂孔；SIS平片组在裂孔缝合后，于食管后方放置“U”形SIS平片加固膈肌，并用医用组织胶固定；立体SIS补片组在裂孔缝合后使用术中拼接成型的三维立体SIS补片，其上层钥匙孔型补片环周加固膈肌，中间筒状结构包绕腹段食管，下层小钥匙孔型补片覆盖于胃食管交界处，同样以医用胶固定。术后3个月进行剖腹探查，评估补片整合及疝复发情况，并进行生物力学测试和组织学分析。结果 所有动物手术顺利完成，无死亡或严重并发症。SIS平片组与立体SIS补片组手术时间较无补片组略长，但出血量相似。术后3个月均未见疝复发或补片移位。生物力学测试显示，SIS平片组与立体SIS补片组的极限载荷及杨氏模量均明显高于无补片组。组织学结果显示，补片组均出现新生血管与胶原沉积，其中立体SIS补片组在膈肌环周修复及膈食管韧带样结构形成方面更为显著。结论 立体SIS补片在猪LHHR模型中操作可行，短期安全有效，能够环周增强膈肌并促进膈食管韧带样组织重建，为降低术后复发和重建抗反流屏障提供新的思路。

Abstract:

Background and Aims Laparoscopic hiatal hernia repair (LHHR) is the gold-standard surgical treatment for hiatal hernia (HH), but postoperative recurrence remains a challenge due to hiatal enlargement and disruption of the phrenoesophageal ligament. This study aimed to assess the feasibility, safety, and short-term efficacy of a novel three-dimensional small intestinal submucosa (3D-SIS) patch designed for circumferential crural reinforcement and ligament-like reconstruction in a porcine LHHR model.Methods Twelve healthy pigs (35-40 kg) were equally randomized into non-mesh group, SIS flat patch group, and 3D-SIS patch group. All animals underwent LHHR and Nissen fundoplication under general anesthesia. In the non-mesh group, the hiatal defect was closed with interrupted sutures. In the SIS flat patch group, a U-shaped SIS patch was placed posterior to the esophagus to reinforce the crura and fixed with medical glue. In the 3D-SIS patch group, an intraoperatively assembled three-dimensional patch was applied, consisting of an upper keyhole-shaped layer for circumferential diaphragmatic reinforcement, a tubular middle part encircling the abdominal esophagus, and a lower small keyhole-shaped patch covering the gastroesophageal junction, all fixed with medical glue. After 3 months, laparotomy was performed to assess recurrence, patch integration, and complications, followed by biomechanical and histological evaluations.Results All procedures were completed successfully with no deaths or major complications. Operative time was slightly longer in the patch groups, while blood loss was similar. No hernia recurrence or patch migration was observed at 3 months. Biomechanical testing revealed higher ultimate load and Young's modulus in both SIS groups than in the non-mesh group. Histological analysis demonstrated neovascularization and collagen deposition in the patch groups, with the 3D-SIS patch showing more complete circumferential integration and ligament-like tissue formation.Conclusion The 3D-SIS patch is feasible and safe in porcine LHHR. It provides circumferential diaphragmatic reinforcement and promotes phrenoesophageal ligament-like regeneration, offering a new concept for reducing postoperative recurrence and reconstructing the anti-reflux barrier.