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Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial

The BOOP study: Bi-layer and connector, On-lay, and On-lay with Plug for inguinal hernia repair

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Abstract

Background

Dissection requirements differ between various methods for inguinal hernia repair, which may affect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected following three principally different techniques for primary inguinal hernia repair.

Methods

A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year and 3 years.

Results

The follow-up rates were 100, 99.8, 98.7 and 95.3%, respectively. The mean operation time was shorter for P (35.5 min, P < 0.001) and PHS (37.4 min, P < 0.02) versus L (40.4 min). More than 85% of the procedures were performed under local anaesthesia. There were no statistically significant differences between the groups concerning early or late complications, return to full functional ability, early pain response, analgesic consumption or the studied late-outcome parameters after 3 years of observation. Seven (1.5%) evenly distributed recurrences were registered.

Conclusion

All of the techniques are suitable for operation under local anaesthesia. The PHS and P techniques can be performed with shorter operation times than the L method. Early and late outcomes are, however, comparable, with no significant differences concerning complication rates, return to full functional status and/or pain response.

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Acknowledgments

This study was partially sponsored by Bard Norden AB (Helsingborg, Sweden) and the Ethicon Division of Johnson & Johnson AB (Sollentuna, Sweden). Neither the principal investigator (JD) nor any other participants had any personal financial interests whatsoever in the outcome of the study. Preliminary results of the study have been presented at the Swedish Surgical Society Meetings in 2002, 2004 and 2007, and at the 26th and 29th International Congresses of the European Hernia Society Meetings in Prague, Czech Republic, 2004, and in Athens, Greece, 2007. The authors extend their gratitude to the excellent secretarial assistance of Helen Bredstenslien, Britt-Marie Ingmansson and Carina Bergendahl-Kristensson, all at the Frölunda Specialist Hospital.

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Authors and Affiliations

  1. Department of Surgery, Frölunda Specialist Hospital/University of Gothenburg, Västra Frölunda, Box 138, 421 22, Gothenburg, Sweden

    J. Dalenbäck, C. Andersson, O. Magnusson, G. Rimbäck & N. Wedel

  2. Department of Surgery, Lundby Hospital, Gothenburg, Sweden

    B. Anesten, S. Eklund & B. Stenquist

  3. Department of Surgery, Mölndals Hospital/Sahlgrenska University Hospital, Gothenburg, Sweden

    S. Björck

Authors
  1. J. Dalenbäck
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  2. C. Andersson
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  3. B. Anesten
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  4. S. Björck
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  5. S. Eklund
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  6. O. Magnusson
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  7. G. Rimbäck
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  8. B. Stenquist
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  9. N. Wedel
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Correspondence to J. Dalenbäck.

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Dalenbäck, J., Andersson, C., Anesten, B. et al. Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. Hernia 13, 121–129 (2009). https://doi.org/10.1007/s10029-008-0443-4

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  • DOI: https://doi.org/10.1007/s10029-008-0443-4

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