Evaluation of the safety and effectiveness of crural reinforcement with bio-a(®) or phasix-st(®) mesh: results from a multicenter study

评估使用 bio-a® 或 phasix-st® 网片进行小腿加固的安全性和有效性:一项多中心研究的结果

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Abstract

BACKGROUND: Absorbable synthetic meshes have gained increasing acceptance for crural reinforcement during hiatus hernia (HH) repair because their safety profile and the potential of reducing recurrence rates. Bio-A(®) (Gore Medical, Newark, DE, USA) and Phasix-ST(®) (C.R. Bard, Inc./Davol, Inc., Warwick, RI, USA) are the most commonly used meshes. While previous single-arm studies have been published, there are no articles reporting the comparison between Phasix-ST(®) vs. Bio-A(®). AIM: Compare safety, efficacy, recurrence rates, and quality of life after laparoscopic HH repair and cruroplasty reinforced with either Bio-A(®) or Phasix-ST(®) mesh. METHODS: Retrospective multicenter study (September 2011- December 2024). All patients that underwent minimally invasive HH repair with Phasix-ST(®) or Bio-A(®) reinforced cruroplasty and Toupet fundoplication were included. RESULTS: Overall, 271 patients were included. Bio-A(®) reinforcement was utilized in 46.8% of patients. The median follow-up time was 94 (IQR 21) months for Bio-A(®) and 51 (IQR 17) months for Phasix-ST(®) mesh. Hernia recurrence was diagnosed in 10.1% of patients with similar rates for Phasix-ST(®) vs. Bio-A(®) (7.8% vs. 12.6%; p = 0.28). The regression analysis showed that Phasix-ST(®) (HR 0.66), 'keyhole' configuration (HR 0.81), hernia type III-IV (HR 1.38), and recurrent HH (HR 1.27) were not independent predictor or protective factors for recurrence. The 55-month recurrence free probability for Bio-A(®) vs. Phasix-ST(®) was comparable (86.2% vs. 91.8%; p = 0.132). CONCLUSIONS: This study shows that Bio-A(®) and Phasix-ST(®) are equally safe for crural reinforcement during HH repair. Due to the longer absorption rate, Phasix ST(®) might presumably confer enhanced hiatal protection early in the course of the follow-up.

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