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UltraPro Hernia System, Prolene Hernia System and Lichtenstein for primary inguinal hernia repair: 3-year outcomes of a prospective randomized controlled trial

Abstract

Purpose

Chronic pain and discomfort are common after inguinal hernia repair (IHR). In this study, results from a 3-year follow-up from a randomized controlled study comparing three different mesh repairs for postoperative pain, discomfort, Quality of Life (QoL) and patient satisfaction are reported.

Methods

Between November 1, 2006 and January 31, 2009, 309 men, who underwent day surgery for primary unilateral inguinal hernia under local anesthesia, were randomized to three different mesh repairs; UltraPro Hernia System (U), Prolene Hernia System (P) and Lichtenstein procedure (L).

Results

Preoperatively, there were no differences between groups regarding demographics, symptoms, inguinal pain or QoL (SF-36 and a hernia-specific questionnaire). Operating time, postoperative pain, complications and time to full recovery were similar. At 36 months, 21 patients indicated pain [L, n = 6, P, n = 6 and U, n = 9; VAS (median (IQR)): L 0.4 (0.2–1.7), P 0.2 (0.1–2.3) and U 1.6 (0.7–4.6), p = ns]. Physical QoL was reduced in all groups before surgery and was similarly increased to normal levels after 3 months without further changes throughout the study. Although 92 % of participants were satisfied, sixteen percent reported any discomfort from the groin (ns between groups). Five recurrences were reported (L, n = 2, P, n = 1 and U, n = 2, p = ns).

Conclusions

After 3 years of follow-up, all three procedures provided equally good results regarding, pain, discomfort and QoL and could therefore be recommended for primary IHR in LA.

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Abbreviations

IHR:

Inguinal hernia repair

QoL:

Quality of life

SF-36:

Short form 36

VAS:

Visual analogue scale

PCS:

Physical component score

MCS:

Mental component score

N:

No inguinal pain preoperatively

P:

Reported inguinal pain preoperatively

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Acknowledgments

This work was supported by grants from the Swedish Research Council (No 09101), Karolinska Institutet, Stockholm, Stockholm City Council, and The Erling-Persson Family Foundation, Sweden. We would like to thank Karin Sadarangani-Lindström, Anette Bratt, Monica Johansson and Charlotte Norberg-Jönsson for their assistance in patient recruitment, excellent nursing and technical support.

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Correspondence to J. Magnusson.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study (KCTR-CT20090022) was approved by the regional ethics committee.

Informed consent

All patients included in the study gave their written informed consent.

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Magnusson, J., Nygren, J., Gustafsson, U.O. et al. UltraPro Hernia System, Prolene Hernia System and Lichtenstein for primary inguinal hernia repair: 3-year outcomes of a prospective randomized controlled trial. Hernia 20, 641–648 (2016). https://doi.org/10.1007/s10029-016-1507-5

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  • DOI: https://doi.org/10.1007/s10029-016-1507-5

Keywords

  • Inguinal hernia
  • UHS
  • PHS
  • Lichtenstein
  • SF-36
  • Pain
  • Quality of life