Background <p>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<sup>®</sup> (Gore Medical, Newark, DE, USA) and Phasix-ST<sup>®</sup> (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<sup>®</sup> vs. Bio-A<sup>®</sup>.</p> Aim <p>Compare safety, efficacy, recurrence rates, and quality of life after laparoscopic HH repair and cruroplasty reinforced with either Bio-A<sup>®</sup> or Phasix-ST<sup>®</sup> mesh.</p> Methods <p>Retrospective multicenter study (September 2011- December 2024). All patients that underwent minimally invasive HH repair with Phasix-ST<sup>®</sup> or Bio-A<sup>®</sup> reinforced cruroplasty and Toupet fundoplication were included.</p> Results <p>Overall, 271 patients were included. Bio-A<sup>®</sup> reinforcement was utilized in 46.8% of patients. The median follow-up time was 94 (IQR 21) months for Bio-A<sup>®</sup> and 51 (IQR 17) months for Phasix-ST<sup>®</sup> mesh. Hernia recurrence was diagnosed in 10.1% of patients with similar rates for Phasix-ST<sup>®</sup> vs. Bio-A<sup>®</sup> (7.8% vs. 12.6%; <i>p</i> = 0.28). The regression analysis showed that Phasix-ST<sup>®</sup> (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<sup>®</sup> vs. Phasix-ST<sup>®</sup> was comparable (86.2% vs. 91.8%; <i>p</i> = 0.132).</p> Conclusions <p>This study shows that Bio-A<sup>®</sup> and Phasix-ST<sup>®</sup> are equally safe for crural reinforcement during HH repair. Due to the longer absorption rate, Phasix ST<sup>®</sup> might presumably confer enhanced hiatal protection early in the course of the follow-up.</p>

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

  • Alberto Aiolfi,
  • Davide Bona,
  • Sara De Bernardi,
  • Francesca Lombardo,
  • Michele Manara,
  • Gianluca Bonitta,
  • Quan Wang,
  • Marta Cavalli,
  • Giampiero Campanelli,
  • Luigi Bonavina

摘要

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.