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Medium term (> 12 months) outcomes after laparoscopic hiatal hernia repair without conventional fundoplication using PH4B-mesh implant (Phasix™) in 176 reflux patients: experience and technique

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Abstract

Background

Hiatal mesh repair remains a controversial topic among anti-reflux surgeons. Biosynthetic mesh cruroplasty may prevent early recurrence while avoiding late esophageal erosion and strictures associated with non-resorbable materials. So far, medium-term results on hiatal PH4B (Poly-4-Hydroxybutyrate) mesh repair from high-volume centers are lacking.

Methods

We analyzed the medium-term efficacy and safety of PH4B mesh cruroplasty in 176 consecutive patients (≥ 18 years) with symptomatic hiatal hernias. Treatment failure was defined as the clinical recurrence of reflux symptoms. Patients could choose between mesh augmented hiatal repair (combined with a modified anterior hemifundoplication and fundophrenicopexy), Nissen fundoplication, and magnetic sphincter augmentation at their discretion. We also describe the surgical approach to mesh augmented hiatal repair used at our center.

Results

On average, patients were 55 (± 14) years old and followed up for 22 (± 7; sum: 3931) months. Treatment failed in 6/176 (3%, 95% CI: 2–7%) patients. The 24-month Kaplan–Meier failure estimate was 2.8% (95% CI: 0.4–5%). Each centimeter in hernia size increased the risk of failure by 52% (p = 0.02). Heavier patients (BMI > 27) had an 11% higher probability of clinical symptom recurrence (p = 0.03). The dysphagia and bloating/gas rate were 13/176 (7%), each. 8 (5%) patients required endoscopy due to dysphagia but without intervention. No serious complications, including mesh infection and erosion, or fatalities, occurred.

Conclusion

Augmented PH4B mesh cruroplasty without conventional fundoplication shows excellent intermediate-term results in patients with reflux disease due to hiatal hernia. Around one in thirty patients experience treatment failure within 2 years of surgery. Hernia size and overweight are key determinants of treatment failure.

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Data availability

Data is not publicly available by German data protection regulations.

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Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

  1. Department of Surgery, Klinik für MIC, Berlin, Germany

    B Siemssen, P M Dahlke & M J Ibach

  2. Experimental and Clinical Research Center (ECRC), a cooperation of Charité—Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine (MDC), Berlin, Germany

    F Behrens

  3. Medizinische Hochschule Brandenburg, Zentrum Für Innere Medizin Universitätsklinikum Brandenburg an der Havel, Brandenburg, Germany

    F Hentschel

Authors
  1. B Siemssen
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  2. P M Dahlke
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  3. F Behrens
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  4. F Hentschel
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  5. M J Ibach
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Corresponding author

Correspondence to B Siemssen.

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Ethical approval

All procedures performed were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. 

Informed consent

Informed consent was obtained from all individual participants included in the study.

Conflict of Interest

Dr. med. Björn Siemssen reports speaker consultancy fees on behalf of C. R. Bard, Inc. The other authors have no conflict of interest to declare.

Human and animal rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The authors did not carry out animal studies for this article.

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Appendix

Appendix

A: Fundophrenicopexy—The yellow circle marks the single suture fixating the fundus to the diaphragm. The blue circle marks the single suture to reinforce the angle of his.

figure a

B: Hemifundoplication—The three green arrows mark the attachment with single sutures of the fundus to the anterolateral esophagus.

figure b

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Siemssen, B., Dahlke, P.M., Behrens, F. et al. Medium term (> 12 months) outcomes after laparoscopic hiatal hernia repair without conventional fundoplication using PH4B-mesh implant (Phasix™) in 176 reflux patients: experience and technique. Hernia (2024). https://doi.org/10.1007/s10029-024-02999-w

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