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Coated poly-4-hydroxybutyrate (Phasix ST™) mesh is safe and effective for hiatal hernia repair: our institutional experience and review of the literature

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Abstract

Background

Poly-4-hydroxybutyrate (P4HB) is a bioabsorbable mesh with a non-adhesive coating on one side that is being used to reinforce the hiatus during hiatal hernia repair; however, there is limited data regarding its use. The aim of this study was to investigate outcomes after hiatal hernia repair using this mesh at our institution and through a review of the literature.

Methods

An institutional review board-approved prospective database was retrospectively reviewed for all patients undergoing hiatal hernia repair from April 2018 to December 2022. A systematic review with meta-analysis was conducted to evaluate outcomes using P4HB coated mesh.

Results

In our institutional cohort, there were 230 patients (59 males; 171 females) with a mean follow-up of 20 ± 14.6 months. No mesh-related complications occurred. Hernia recurrence was diagnosed in 11 patients (4.8%) with a median time to recurrence of 16 months. In the systematic review, 4 studies with 221 patients (76 males; 145 females) were included. Median follow-up ranged from 12 to 27 months. Recurrence rate in these studies was reported from 0 to 8.8%, with a total of 12 recurrences identified. Like our institutional cohort, no mesh-related complications were reported. After our recurrences were combined with those from the systematic review, a total of 23 recurrences were included in the meta-analysis. Our meta-analysis revealed a low recurrence rate following hiatal hernia repair with P4HB coated mesh (incidence rate per 100 person-years, 2.82; 95% confidence interval, 1.60, 4.04).

Conclusion

P4HB coated mesh is safe and effective for hiatal hernia repairs.

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Authors and Affiliations

  1. Department of Minimally Invasive Surgery, Baylor University Medical Center, Dallas, TX, USA

    Lucas Fair, Marc Ward & Bola Aladegbami

  2. Center for Advanced Surgery, Baylor Scott and White Health, Dallas, TX, USA

    Lucas Fair, Marc Ward, Bola Aladegbami & Steven Leeds

  3. Texas A&M College of Medicine, Bryan, TX, USA

    Marc Ward, Preston Adhikari, Daniel Tran, Bola Aladegbami & Steven Leeds

  4. Research Institute, Baylor Scott and White Health, Dallas, TX, USA

    Lucas Fair, Emerald Pina & Gerald Ogola

  5. Baylor Health Sciences Library, Baylor Scott and White Health, Dallas, TX, USA

    Sudha Ramakrishnan

  6. Department of Minimally Invasive Surgery, Baylor University Medical Center, 3417 Gaston Avenue, Suite 965, Dallas, TX, 75246, USA

    Steven Leeds

Authors
  1. Lucas Fair
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  2. Marc Ward
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  6. Sudha Ramakrishnan
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  7. Gerald Ogola
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  8. Bola Aladegbami
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Contributions

PA, MW, LF, DT, EP, SR, GO, BA, and SL contributed to study conception, study design, and data acquisition. GO performed data analysis and interpretation. PA, LF, and SL drafted the original manuscript. All authors provided final approval of the submitted version of the manuscript.

Corresponding author

Correspondence to Steven Leeds.

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Disclosures

Lucas Fair, Marc, Ward, Preston Adhikari, Daniel Tran, Emerald Pina, Sudha Ramakrishnan, Gerald Ogola, Bola Aladegbami, and Steven Leeds have no conflicts of interest or financial ties to disclose.

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Fair, L., Ward, M., Adhikari, P. et al. Coated poly-4-hydroxybutyrate (Phasix ST™) mesh is safe and effective for hiatal hernia repair: our institutional experience and review of the literature. Surg Endosc 38, 830–836 (2024). https://doi.org/10.1007/s00464-023-10604-x

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  • DOI: https://doi.org/10.1007/s00464-023-10604-x

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