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Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial)

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Abstract

Background

Recurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce post-operative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair.

Methods

In a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro® or a Prolene® mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score >3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities.

Results

At 3-month follow-up, the incidence of pain (NRS 4–10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21–3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months.

Conclusion

Three months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint.

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Acknowledgments

A Research Grant has been assigned to the Diakonessenhuis/Hernia Centre Zeist by Johnson & Johnson to partially support all research regarding the endoscopic totally extraperitoneal hernia repair.

Disclosures

Drs. J.P.J. Burgmans, Drs. C.E.H. Voorbrood, Dr. N. Smakman, Dr. G.J. Clevers, Dr. P.H.P. Davids, Dr. E.J.M.M. Verleisdonk and Dr. T. van Dalen confirm that a Research Grant has been assigned to the Diakonnessenhuis Utrecht/Zeist, or more specifically to the Hernia Centre Zeist, by Johnson & Johnson. The Research Grant is intended to support all manuscripts regarding the results and complications of the totally extraperitoneal (TEP) endoscopic hernia repair. This study itself is not directly subject of the Research Grant. Johnson & Johnson has and will have no access to data upon which the manuscript is based. A copy of the manuscript will only be provided at acceptance of the manuscript. Johnson & Johnson has no influence on the (subject of) this study whatsoever. Objectivity of data is therefore guaranteed, and there is no conflict of interest. There are no (other) commercial associations that might pose a conflict of interest in connection with the submitted article. Dr. N. Schouten, Dr. S. Elias, Dr. M.E. Hamaker and Dr. R.K.J. Simmermacher have no conflicts of interest or financial ties to disclose.

Author information

Authors and Affiliations

  1. Department of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands

    J. P. J. Burgmans, C. E. H. Voorbrood, N. Smakman, G. J. Clevers, P. H. P. Davids, E. J. M. M. Verleisdonk & T. van Dalen

  2. Department of Surgery, Atrium Medical Centre Parkstad, Heerlen, The Netherlands

    N. Schouten

  3. Julius Centre for Health Sciences and Primary Care, Utrecht, The Netherlands

    S. Elias

  4. Department of Geriatric Medicine, Diakonessenhuis Utrecht/Zeist, Zeist, The Netherlands

    M. E. Hamaker

  5. Department of Surgery, UMCU, Utrecht, The Netherlands

    R. K. J. Simmermacher

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  1. J. P. J. Burgmans
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  2. C. E. H. Voorbrood
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  3. N. Schouten
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  6. G. J. Clevers
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  7. P. H. P. Davids
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  9. M. E. Hamaker
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  10. R. K. J. Simmermacher
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  11. T. van Dalen
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Corresponding author

Correspondence to J. P. J. Burgmans.

Additional information

Trial registration: The TULP study is registered in the Dutch Trial Register (NTR2131).

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Burgmans, J.P.J., Voorbrood, C.E.H., Schouten, N. et al. Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial). Surg Endosc 29, 3171–3178 (2015). https://doi.org/10.1007/s00464-014-4049-x

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