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Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study

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Abstract

Purpose

Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown.

Methods

We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up.

Results

Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009).

Conclusion

Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.

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References

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Acknowledgments

The authors thank the project nurses at all the centres for helping with data collection. The study was supported by a grant from Baxter Healthcare Corporation, Bioscience Division. The sponsor of the study had no influence on the idea or design of the study protocol, data collection, analysis or interpretation, manuscript writing or final decision to submit the paper for publication.

Conflict of interest

JR, TB and SA have received research grants and/or lecture fees from Johnson & Johnson, Covidien and Baxter Healthcare Corporation. LNJ received research grants from Covidien. JRE received travel grants from Baxter Healthcare.

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Authors and Affiliations

  1. Department of Surgery D, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark

    J. R. Eriksen, S. Assaadzadeh & J. Rosenberg

  2. Department of Surgery, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark

    T. Bisgaard

  3. Department of Surgery K, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

    L. N. Jorgensen

Authors
  1. J. R. Eriksen
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  2. T. Bisgaard
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  3. S. Assaadzadeh
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  4. L. N. Jorgensen
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  5. J. Rosenberg
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Corresponding author

Correspondence to J. R. Eriksen.

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Eriksen, J.R., Bisgaard, T., Assaadzadeh, S. et al. Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study. Hernia 17, 511–514 (2013). https://doi.org/10.1007/s10029-013-1101-z

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  • DOI: https://doi.org/10.1007/s10029-013-1101-z

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