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Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair

An Erratum to this article was published on 15 June 2013

Abstract

Background

Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)  compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks fixation of mesh during TAPP.

Methods

One hundred and twelve men with unilateral inguinal hernia were enrolled. Primary outcome was pain during coughing on postoperative day 1. Secondary outcomes were postoperative scores of pain at rest, discomfort, and fatigue (day 1 and cumulated day 0–3), incidence of moderate/severe nausea and/or vomiting, foreign-body sensation, and recurrence after 6 months. Outcome measures were assessed by visual analogue scale (VAS, 0–100 mm), verbal rating scale (no, light, moderate or severe) and numerical rating scales (NRS, 1–10).

Results

One hundred patients were available for analysis. The fibrin group (n = 50) had significantly less pain during coughing on day 1 compared with the tacks group (n = 50) [median 23 (range 0–80) vs 35 (2–100) mm] (p = 0.020). Moreover, day 1 scores and all cumulated scores of pain during rest, discomfort, and fatigue were significantly lower in the fibrin group compared with the tacks group (all p-values ≤ 0.02). There was no significant difference in the incidence of nausea and/or vomiting (p > 0.05) or recurrence (fibrin glue n = 2, tacks n = 0, p = 0.241). Incidence of foreign-body sensation was significantly lower in the fibrin group at 1 month (p = 0.006).

Conclusions

Fibrin glue compared with tacks fixation improved the early postoperative outcome after TAPP. The trial was registered at clinicaltrials.gov NCT01000116.

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Acknowledgments

The authors thank Region Zealand’s Health Research Fund (RESUS) for financial support and private hospital Aleris-Hamlet for use of their facilities. Additionally, we would like to thank Research Nurse Pernille Strandfelt for assistance in data collection during the trial.

Disclosures

Mette A. Tolver has received payment for lectures by Baxter Healthcare. Jacob Rosenberg has received payment for expert testimony from Baxter Healthcare and has had travel/accommodation expenses for international meetings covered by Johnson & Johnson. Poul Juul has no conflicts of interest. The Bisgaard has received support from Johnson & Johnson, Covidien and Baxter Healthcare and travel/accommodation expenses for international meetings covered by Baxter Healthcare.

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Correspondence to Mette A. Tolver.

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Tolver, M.A., Rosenberg, J., Juul, P. et al. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc 27, 2727–2733 (2013). https://doi.org/10.1007/s00464-012-2766-6

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Keywords

  • Fibrin glue
  • Tacks
  • TAPP
  • Pain
  • Fatigue
  • Discomfort