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Prospective double-blind randomized study comparing Perfix® plug-and-patch with Lichtenstein patch in inguinal hernia repair: one year quality of life results

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Summary

Background

The 14 day results of this study reported elsewhere demonstrated that the Perfix® plug-and-patch was as effective as the Lichtenstein patch but not as cost-effective. The present analysis looks at the results at one year to measure quality of life between the two groups.

Patients and Methods

141 patients were randomly allocated in a doubleblind manner to receive either a Lichtenstein patch (patch) or a Perfix® plug- and-patch (plug-and-patch) for primary inguinal hernia. Quality of life at 6 months and one year was assessed by the short-form 36 (SF36). On a 3 point scale patients were asked at one year to rate groin, wound and testicular discomfort.

Results

Physical function by SF36 was similar in the 2 groups at 6 months, but at one year in the patch group (95.11 +/-20.07) was significantly better (p < 0.05) than physical function in the plug-and-patch group (82.5 ± 20.98). At one year the number of patients with wound discomfort limiting work or social activities was significantly greater in patients receiving the plug-and-patch (n = 12) compared with patients receiving the patch (n = 4), p < 0.031. At one year, 4 of 70 patients receiving the plug-and-patch had required reoperation to remove the preformed plug-and-patch device and replace it with a flat Lichtenstein patch, because of wound pain which was limiting activity.

Conclusion

A significant proportion of patients suffer chronic pain after placement of a Perfix® plug-and-patch for primary inguinal hernia repair. Removal of the Perfix® device is required in approximately i in 20 patients (5.6% in this series).

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Correspondence to A. N. Kingsnorth.

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Kingsnorth, A.N., Hyland, M.E., Porter, C.A. et al. Prospective double-blind randomized study comparing Perfix® plug-and-patch with Lichtenstein patch in inguinal hernia repair: one year quality of life results. Hernia 4, 255–258 (2000). https://doi.org/10.1007/BF01201078

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  • DOI: https://doi.org/10.1007/BF01201078

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