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Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue

  • Controlled Clinical Trial
  • Published:
Langenbeck's Archives of Surgery Aims and scope Submit manuscript

Abstract

Purpose

The method of anchoring the mesh in laparoscopic ventral hernia repair is claimed to cause postoperative pain, affecting the quality of life of the patients. The aim of this randomized study was to compare the effect of three types of fixation devices on postoperative pain, patient quality of life, and hernia recurrence.

Methods

Patients with ventral hernias between 2 and 7 cm were randomized into one of three mesh fixation groups: permanent tacks (Protack™), absorbable tacks (Securestrap™), and absorbable synthetic glue (Glubran™). The primary endpoint was pain on the second postoperative day, measured on a visual analogue scale. Quality of life and recurrence rate were secondary endpoints and investigated through questionnaires and clinical examination at follow-up visits 1, 6, and 12 months after surgery.

Results

Seventy-five non-consecutive patients were included in the study, with 25 patients in each group. There was no significant difference between groups for unspecified pain on the second postoperative day (p = 0.250). The DoloTest™ values were 55.3 ± 28.9 mm, 43.5 ± 28.5 mm, and 55.9 ± 26.3 mm for permanent tacks, absorbable tacks, and synthetic glue, respectively. No differences were observed between groups with respect to quality of life of the patients and hernia recurrence rate.

Conclusions

In patients with small- and medium-sized ventral hernias, the type of fixation device did not affect the immediate or long-term postoperative pain, quality of life, or recurrence rate when comparing permanent tacks, absorbable tacks, and synthetic glue for mesh fixation.

Trial registration

NCT01534780

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Acknowledgments

The authors thank Ass. Professor Mogens Erlandsen, Department of Biostatistics Aarhus University, for helping with the statistics both during the planning of the study and data analysis.

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Authors and Affiliations

  1. Department of Surgery, Regional Hospital Horsens, Sundvej 30, 8700, Horsens, Denmark

    Sanne Harsløf, Pia Krum-Møller, Nellie Zinther & Hans Friis-Andersen

  2. Department of Surgery, Randers, Denmark

    Thorbjørn Sommer

  3. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark

    Pål Wara

Authors
  1. Sanne Harsløf
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  2. Pia Krum-Møller
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  3. Thorbjørn Sommer
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  4. Nellie Zinther
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  5. Pål Wara
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  6. Hans Friis-Andersen
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Contributions

Study conception and design: S. Harsløf, N. Zinther, H. Friis-Andersen. Acquisition of data: S. Harsløf, P. Møller, T. Sommer, N. Zinther, P. Wara, H. Friis-Andersen. Analysis and interpretation of data: S. Harsløf, P. Møller, T. Sommer, N. Zinther, P. Wara, H. Friis-Andersen. Drafting of the manuscript: S. Harsløf. Critical revision of the manuscript: S. Harsløf, P. Møller, T. Sommer, N. Zinther, P. Wara, H. Friis-Andersen.

Corresponding author

Correspondence to Sanne Harsløf.

Ethics declarations

The study was approved by The Central Denmark Region Committees on Health Research Ethics (permit number 1-10-72-89-14) and was performed according to the ethical standards of the abovementioned national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Participating patients received verbal and written information about the trial, before informed consent was obtained.

Conflict of interest

The authors declare that they have no conflict of interest.

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Harsløf, S., Krum-Møller, P., Sommer, T. et al. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg 403, 529–537 (2018). https://doi.org/10.1007/s00423-018-1676-z

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  • DOI: https://doi.org/10.1007/s00423-018-1676-z

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