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多中心前瞻性临床试验:应用肝源性猪医用修补网片腹腔镜修复食管裂孔疝。

A multi-center, prospective clinical trial of a hepatic derived porcine surgical mesh for the laparoscopic repair of symptomatic paraesophageal hernias.

机构信息

Cleveland Clinic, Cleveland, OH, USA.

Monmouth Medical Center, Long Branch, NJ, USA.

出版信息

Am J Surg. 2019 Aug;218(2):315-322. doi: 10.1016/j.amjsurg.2019.03.025. Epub 2019 Apr 1.

DOI:10.1016/j.amjsurg.2019.03.025
PMID:30954232
Abstract

INTRODUCTION

We report the results of a multicenter trial evaluating a unique, biological mesh (MIROMESH) derived from decellularized porcine liver for hiatal cruralplasty during laparoscopic PEHR.

METHODS

41 subjects underwent a laparoscopic PEHR which included primary crural closure, and MIROMESH onlay. Subjects were assessed at 2-weeks and 6, 12, 18 and 24 months using the SF-36, GERD-HRQL questionnaire, and VAS GERD related symptoms, and UGI.

RESULTS

Mean procedure time was 143.0 (±45.2) minutes, 93% had a Type III hiatal hernia and median LOS was 3 days. Of 27 patients available for 2 years follow up, no patients required surgical reintervention for symptomatic hernia recurrence or adverse events. Radiographic follow up revealed a 10% hiatal hernia recurrence rate. GERD HRQL scores were significantly improved from baseline to two years follow up. All the GERD symptoms measured showed significant and sustained improvement at all post-operative time periods.

CONCLUSION

The utilization of MIROMESH for crural reinforcement during laparoscopic PEHR resulted in excellent symptomatic improvement in our multicenter trial with a 10% 2 year radiographic recurrence rate.

摘要

简介

我们报告了一项多中心试验的结果,该试验评估了一种独特的、源自脱细胞猪肝的生物网片(MIROMESH),用于腹腔镜 PEHR 中的裂孔疝修补术。

方法

41 名受试者接受了腹腔镜 PEHR 手术,包括裂孔边缘的初级闭合和 MIROMESH 覆盖。在术后 2 周和 6、12、18 和 24 个月,使用 SF-36、GERD-HRQL 问卷和 VAS 与 GERD 相关的症状以及 UGI 对受试者进行评估。

结果

平均手术时间为 143.0(±45.2)分钟,93%的患者为 III 型食管裂孔疝,中位 LOS 为 3 天。在 27 名可进行 2 年随访的患者中,没有患者因症状性疝复发或不良事件需要手术再次干预。放射学随访显示疝复发率为 10%。从基线到 2 年随访,GERD HRQL 评分均显著改善。所有测量的 GERD 症状在所有术后时间段均显示出显著且持续的改善。

结论

在腹腔镜 PEHR 中使用 MIROMESH 进行裂孔边缘加固,在我们的多中心试验中取得了极好的症状改善效果,2 年放射学复发率为 10%。

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